SSTR2 Imaging With [68Ga]Ga-DOTA-TOC PET/CT in NPC
ConditionNasopharyngeal Carcinoma (NPC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen
About this trial
This is an investigator-initiated, single-center clinical trial designed to evaluate the feasibility of \[68Ga\]Ga-DOTA-TOC positron emission tomography (PET) scan in patients with Epstein-Barr virus (EBV) related nasopharyngeal carcinome (NPC) prior to and three weeks after the start of induction chemotherapy or concurrent chemoradiotherapy (CRT). Archival tumor tissue from the diagnostic biopsy will be used to perform somatostatin receptor 2 (SSTR2) immunohistochemistry (IHC). Blood samples will be drawn at baseline, after three weeks, after completion of induction chemotherapy if applicable, and after CRT.
Eligibility criteria
Qualifiers
Stage IB-IVA NPC (AJCC 9th edition), EBV positive determined by Epstein-Barr virus-encoded RNA (EBER).
Planned treatment with induction chemotherapy or CRT without induction chemotherapy.
Age ≥ 18 years.
Signed informed consent.
Disqualifiers
Previous treatment with chemotherapy or radiotherapy for NPC.
Treatment with any investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to [68Ga]Ga-DOTA-TOC injection.
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or that may affect the interpretation of the results or render the patient at high risk from complications.
Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
Trial design
Treatments tested in this trial
- [68Ga]Ga-DOTA-TOC PET imaging
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov