[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurofibroma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurofibroma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100600815","phase-1-feasibility-and-tolerability-of-imlygic-for-the-treatment-of-cutaneous-neurofibromas-in-adults-with-nf1-100600815",false,"NCT07102394","Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1","Inclusion Criteria:\n\n* Males or females age ≥ 18 years who meet the NIH clinical criteria for the diagnosis of NF1\n* Must have ≥8 measureable cNFs. Histologic confirmation of tumor is not necessary in the presence of consistent clinical findings or confirmed genetic testing. A Measurable cNF is defined as a cutaneous lesion that meets these criteria:\n* Singular lesion surrounded by uninvolved skin measuring ≥ 5 mm in the longest diameter but not larger than 5 cm\n\n  1. Not covered by hair\n  2. There is no skin breakdown in the tumor or the skin around it\n  3. Not located in an area that is prone to irritation or trauma.\n  4. A tumor that has not received other therapies such as electrodessication, laser treatment, or prior resection or biopsy.\n  5. Diffusely infiltrating cutaneous neurofibromas, subcutaneous neurofibromas, and plexiform neurofibromas are NOT eligible for treatment as photographic assessments and measurements with calipers or ruler are not possible or reliable.\n  6. Participants must have 6 cNFs that are amenable for excision.\n  7. Participants must be willing to undergo pre- and post-treatment tumor excisions providing fresh tumor tissue; there should be no contraindication for serial biopsies.\n* Karnofsky performance level of ≥ 80%.\n* Adequate organ and bone marrow and other organ function as defined by the following Screening laboratory values:\n\n  1. Absolute neutrophil count ≥ 1,500 cells\u002FµL;\n  2. Platelets ≥ 100 x 103\u002FµL;\n  3. Hemoglobin ≥ 9.5 g\u002FdL;\n  4. Serum albumin ≥ 2.8 g\u002FdL;\n  5. Calculated creatinine clearance at Screening ≥ 60 mL\u002Fmin (by Cockcroft-Gault formula) OR a normal serum creatinine.\n  6. Alanine aminotransferase (ALT) ≤ 2x upper limit of institutional norm\n  7. Total bilirubin value of ≤1.5 x Upper Limit of Normal (ULN) (isolated bilirubin ≥1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%)\n* Participant is willing and able to comply with all aspects of the protocol\n* Ability to understand and willingness to sign written informed consent document(s).\n* Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding during any portion of the study and must use an adequate method to prevent pregnancy during the study period and for 3 months after treatment conclusion and agree not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of 3 months after last dose of study treatment. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment (see the Approved Methods of birth control listed below).\n* For a woman to be determined not of childbearing potential, she must have ≥ 12 months of non-therapy-induced amenorrhea or be surgically or medically sterile.\n* WOCBP must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result at the Baseline visit prior to the first dose of study treatment if the Screening Day serum test was done more than 28 days prior.\n* Male participants are eligible to participate if agreed to the following during the treatment period and for at least 90 days after the last dose of study treatment:\n\n  \\-- Refrain from donating sperm\n* PLUS, either:\n\n  * Be abstinent from heterosexual intercourse and agree to remain abstinent until 90 days after the last study drug treatment; OR\n  * Must agree to use a male condom when having sexual intercourse with a WOCBP and their female partner must utilize one the approved methods of birth control below:\n* Approved Methods of birth control for this study are:\n\n  * Total abstinence\n  * Male or female sterilization (vasectomy in males or surgical removal of ovaries or uterus in females)\n  * Unsterilized male study participants must use a male condom, and their female partner must use one of the methods below:\n  * Unsterilized female study participants must use one of the following highly effective methods listed below:\n* Acceptable birth control methods which are considered highly effective if methods result in a failure rate of less than 1% per year when used consistently and correctly:\n* Combined (estrogen and progestogen containing) hormonal contraceptive that stops the release of eggs from the ovary (oral, intravaginal, or transdermal)\n* Progestogen-only hormonal contraception that stops the release of eggs from the ovary (oral, injectable, implantable)\n* Intrauterine device (IUD)\n* Intrauterine hormone-releasing system (IUS)\n* Bilateral tubal occlusion or bilateral tubal ligation\n\nExclusion Criteria:\n\n* Any underlying medical condition, which in the opinion of the investigator, would make administration of the study drug hazardous or make it difficult to monitor adverse effects.\n* Evidence of immunosuppression for any reason:\n\n  1. Known HIV infection or AIDS\n  2. Acute or chronic active hepatitis B or hepatitis C infection\n  3. Chronic oral or systemic steroid medication use at a dose of \\>10 mg\u002Fday of prednisone or equivalent (steroids with low systemic absorption \\[e.g., triamcinolone hexacetonide\\] is allowed)\n  4. Other signs or symptoms of clinical immune system suppression\n* Open herpetic skin lesions\n* Any anti-herpetic treatment within the last 4 weeks prior to trial participation\n* Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir, valacyclovir, famciclovir, any other antiviral medications), other than intermittent topical use\n* One year since the last treatment for any cancer, and not requiring any ongoing secondary prevention, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.\n* Patients who have had chemotherapy or radiation therapy must have recovered normal organ function as defined above; people who had excisions of basal cell or squamous cell carcinoma, must have healed and the scars must be at least 3 cm away from any cNF being monitored or treated.\n* Active optic glioma or other low-grade glioma or plexiform neurofibroma requiring treatment. a. Participants not requiring treatment are eligible.\n* Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor or strabismus) or long-standing orbito-temporal Plexiform Neurofibroma (PN) (such as visual loss, strabismus) are eligible\n* Patients with marked baseline prolongation of QT\u002FQTc interval (QTc interval \\>470 msec) must be excluded.\n* Previous treatment with IMLYGIC or treatment with Granulocyte-macrophage colony-stimulating factor (GM-CSF)\n* Currently receiving therapy with a Mitogen-Activated Protein Kinase (MEK) inhibitor or treated with a MEK inhibitor in the 6 months prior to the first dose of study treatment.\n* Pregnant or breastfeeding women may not take study drug.\n* Current enrollment or past participation in any other clinical study (excluding observational studies) within 30 days of the first dose of study treatment.\n* Known sensitivity to the study treatment, or components thereof, or drug or other allergy that, could compromise safety of the subject\n* Participants are excluded if they have severe and\u002For uncontrolled medical disease or social situation, which could compromise participation in the study (e.g., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper GI tract ulceration, congestive heart failure, drug or alcohol dependence, etc.).","ALL","18 Years",{"count":18,"type":19},10,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This study is designed to establish the foundation for a new therapy for neurofibromatosis Type I (NF1)-related cutaneous neurofibromas (cNFs) by assessing the feasibility and efficacy of IMLYGIC in adults with NF1 and cNFs who desire local treatment of their cNF due to disfigurement, progression, pain, itching or other concerns. This is a single institutional Phase 1 study with a safety run-in to assess the feasibility and efficacy of IMLYGIC monotherapy in NF1 patients with cNFs. Each 28-day treatment cycle will be defined as intralesional administration of IMLYGIC administered on day 1 and 21 of Cycle 1 and days 7 and 21 for Cycles 2-4 for up to 4 cycles.",[25,26,27,28,29,30],"NF1","Neurofibromatosis","Cutaneous Neurofibroma","Neurofibroma","Von Recklinghausen Disease","Neurofibromas",[25,32,33,34,35,36,37],"neurofibromatosis","cutaneous neurofibroma","IMLYGIC","T-VEC","Neurofibromatosis type 1","neurofibroma","RECRUITING","2026-05-07",{"date":41,"type":42},"2026-05-08","ACTUAL",{"date":44,"type":42},"2026-02-01",{"date":46,"type":19},"2027-12-31",{"name":48,"class":49},"Johns Hopkins University","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":50},"100583796","development-of-patient-reported-outcome-measures-assessing-tumor-visibility-and-appearance-concerns-in-neurofibromatosis-type-1-a-qualitative-study-100583796","NCT06880991","Development of Patient-Reported Outcome Measures Assessing Tumor Visibility and Appearance Concerns in Neurofibromatosis Type 1: A Qualitative Study","* INCLUSION CRITERIA:\n* Participants must self-report a diagnosis of NF1 OR be the caregiver of a child with NF1 (5-17 years old with plexiform neurofibroma \\[pNF\\] or 12-17 years old with cutaneous neurofibroma \\[cNF\\])\n\nThe following for the participant or the caregiver of a child, as appropriate:\n\n* Participants with NF1 must self-report a pNF and\u002For cNF tumor(s) that is visible to that individual OR others\n* Caregivers of a child with NF1 must report a pNF and\u002For cNF tumor(s) that the child has that is visible to the child OR others\n* Age requirements:\n\n  * \\>= 8 years old (participants with pNF)\n  * \\>= 12 years old (participants with cNF)\n  * \\>= 12 years old (participants with pNF and cNF)\n  * \\>= 18 years (caregivers)\n* Access to device with internet\n* Ability to understand English and comfort discussing their medical condition in English\n* The ability of adult participant or caregiver of minor participants to understand and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\n* Physical or cognitive limitations that would prevent them from being able to participate in a focus group or interview, or unwillingness to do so\n* Since we will aim to have no less than 25 percent of participants from underrepresented\\* groups, individuals from represented groups may not be able to participate after we have reached the maximum target for represented groups. Consistent with best practices for scale development and validation, this will help ensure that the measures are appropriate for people from a variety of backgrounds.\n\n  \\* Underrepresented groups are defined as people who identify as African American or Black, American Indian, Alaska Native, Hispanic\u002FLatine, Native Hawaiian, and other Pacific Islander.\n* If saturation has been met within a particular age group, potential participants from that completed age group will no longer be eligible.","5 Years","120 Years",{"count":60,"type":19},110,"OBSERVATIONAL","Background:\n\nNeurofibromatosis 1 (NF1) is a disease that causes tumors to grow along the nerves. These include plexiform neurofibromas (pNF) and cutaneous neurofibromas (cNF). Both pNF and cNF can be visible to other people. These tumors can affect a person s appearance and quality of life. Researchers want to be able to assess changes in appearance before and after treatment for NF1 tumors.\n\nObjective:\n\nTo see if two questionnaires can help assess people s ratings about the appearance of their pNF and cNF tumors.\n\nEligibility:\n\nPeople aged 8 years and older with pNF and people 12 years and older either with cNF or both pNF and cNF. Adult caregivers of children with pNF and cNF are also needed.\n\nDesign:\n\nParticipants will complete questionnaires on paper or by phone, computer, or tablet. They will answer questions about how they look, how they feel, and how they feel about the way they look.\n\nParticipants will meet in at least 1 remote focus group or individual interview. The meeting will last about 1 hour. Each group will include 3 to 5 people, organized by age: 8 to 11 years, 12 to 17 years, 18 to 29 years, and over 30 years. Adult caregivers will meet in a group with other caregivers.\n\nThey will discuss their NF1 symptoms; how their tumors look; how they feel about the way their tumors look; and their daily activities. They will give their opinions about 2 questionnaires about appearance.\n\nThe group and individual meetings will be audio-recorded and transcribed. Information that can reveal individual identities will be removed.",[64,28],"Neurofibromatosis Type 1",[66,67,68],"Qualitative","Focus Groups","Instrument Development","2026-04-28",{"date":71,"type":42},"2026-04-29",{"date":73,"type":42},"2025-04-29",{"date":75,"type":19},"2028-03-31",{"name":77,"class":78},"National Cancer Institute (NCI)","NIH",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":20,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":50},"100454579","evaluation-of-percutaneous-cryotherapy-in-the-treatment-of-plexiform-neurofibromas-and-unresectable-neurofibromas-in-neurofibromatosis-type-1-100454579","NCT05199376","Evaluation of Percutaneous Cryotherapy in the Treatment of Plexiform Neurofibromas and Unresectable Neurofibromas in Neurofibromatosis Type 1","Evaluation of Percutaneous Cryotherapy in the Treatment of Plexiform Neurofibromas and Unresectable Neurofibromas in Neurofibromatosis Type 1 (NF1)","CryoNF1","Inclusion Criteria:\n\n* Age ≥18 years;\n* Patient with neurofibromatosis type 1 according to NIH criteria ;\n* Patient with a benign neurofibromatous lesion that is painful and\u002For generates functional discomfort and is unresectable or with unacceptable scarring ;\n* Neutrophils \\> 1 G\u002Fl in the 14 days prior to inclusion;\n* Adequate coagulation test with normals values (as judged by the investigator);\n* Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment\n* Covered by a medical insurance;\n\nExclusion Criteria:\n\n* Patient treated with concomitant chemotherapy and\u002For targeted therapies ;\n* Any contraindication to a percutaneous cryotherapy procedure, including the need for ice formation within 1 cm of the spinal cord, brain or other critical nerve structures, bowel or bladder (unless active or passive thermal protective maneuvers are performed);\n* Patient with malignant neurofibroma or MPNST ; CT scan without abnormality and if tumor presents a max SUV T\u002FF\\>1.5 ratio, targeted biopsy is required to confirm benign or malignant histology.\n* Patient with neurofibroma in areas at risk for neurological sequelae;\n* Patient with cold urticaria with history of angioedema;\n* Any cognitive impairment or condition that may limit the use of numerical scales and quality of life questionnaires;\n* Patient for whom follow-up does not seem feasible even in the short term;\n* Participation in another clinical trial that may interfere with the evaluation of the primary endpoint;\n* Patient under tutorshio, curatorship or deprived of liberty;\n* Pregnant or breast-feeding woman;\n* Any contraindication to the performance of an MRI\n* Patient with dysplastic neurofibroma",{"count":88,"type":19},30,[90],"NA","Neurofibromatosis type 1 (NF1) is an autosomal dominant disease affecting chromosome 17. It is manifested by a neurogenic tumor proliferation that forms cutaneous, subcutaneous or deep neurofibromas.\n\nNeurofibromas can cause functional discomfort, neurogenic pain that is difficult to treat, and severe cosmetic disorders.\n\nTreatment is essentially surgical. It is sometimes a heavy invasive surgery with complicated postoperative follow-up and significant scarring on the aesthetic level. Currently, no systemic treatment has proven its effectiveness in this pathology.\n\nPercutaneous cryotherapy is a cold thermoablation procedure using fine 17 G needles introduced into the lesion after targeting by imaging. This technique is used in the treatment of soft tissue tumors and desmoid tumors.\n\nThe treatment of neurofibromas with percutaneous cryotherapy is not well known. Encouraging results (unpublished) have been observed in patients with NF1 treated with cryotherapy at the Léon Bérard Center. The beneficial effect was observed in terms of quality of life (in particular, pain) as well as a decrease in tumor size.\n\nOn the basis of this first experience, it appears important to corroborate these preliminary results by a prospective study allowing the use of this technique to treat patients with unresectable or resectable neurofibromas but with mutilating surgery in a NF1 context.",[28,93],"Neurofibroma, Plexiform","2024-02-08",{"date":96,"type":42},"2024-02-09",{"date":98,"type":42},"2022-02-14",{"date":100,"type":19},"2027-02-07",{"name":102,"class":49},"Centre Leon Berard"]