PET Imaging of 68Ga-NOTA-H006 in Malignancy
ConditionTumor, Solid
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorYiHui Guan
About this trial
5T4, also known as trophoblast glycoprotein, is an oncofoetal antigen expressing in fetal development and cancer but rarely in adult. The high expression of 5T4 in malignancy was found be associated with poor clinical outcomes in ovarian, gastric and colorectal cancers. Several antibody drug conjugates are currently under development for cancer therapy in preclinic and clinic stages.
Previously, investigators engineered a 5T4-specific biomolecule with nanomolar binding affinity. Radiolabeling with gallium-68 resulted in 68Ga-NOTA-H006 which showed 5T4 expression in a variety of xenograft models. Thus, the aims of current study are to evaluate the distribution and dosimetry of this novel tracer, and to explore the diagnostic values of 68Ga-NOTA-H006 in malignant tumors.
Eligibility criteria
Qualifiers
Age between 18 and 65 years old.
Pancreatic occupancy is found on imaging and combined with clinical judgment as a patient with pancreatic cancer.
Written informed consent signed by the subject or his/her legal guardian or caregiver.
Willingness and ability to cooperate with all programs of the study.
Disqualifiers
Severe hepatic or renal insufficiency;
Targeted therapy prior to radiotherapy or PET/CT scan. 5T4 expression in existing lesions assessed by immunohistochemistry using antibody clones.
History of serious surgery in the last month.
Those who have participated in other clinical trials during the same period.
Trial design
Treatments tested in this trial
- 68Ga-NOTA-H006 is injected intravenously with a dose of 1.8 MBq[0.05MCi]/kg.
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
YiHui Guan
Lead sponsor
Huashan Hospital
Sponsor institution
Source ClinicalTrials.gov