NCT06982300 SSTR2 Imaging With [68Ga]Ga-DOTA-TOC PET/CT in NPC
| NCT ID | NCT06982300 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University Medical Center Groningen |
| Condition | Nasopharyngeal Carcinoma (NPC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-09-25 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-09-25 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. * Willingness and ability to comply with all protocol required procedures. * Negative serum pregnancy test at screening in women of childbearing potential. * Archival tumor tissue available or consent to undergo a tumor biopsy procedure. Exclusion Criteria: * 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. * Inability to lie in supine position for 25 minutes. * Patients who are pregnant or breastfeeding.
Contact & Investigator
Sjoukje F. Oosting, MD, PhD
PRINCIPAL INVESTIGATOR
University Medical Center Groningen, Dept. of Medical Oncology, Hanzeplein 1, 9713 GZ Groningen, The Netherlands
Frequently Asked Questions
Who can join the NCT06982300 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nasopharyngeal Carcinoma (NPC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06982300 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06982300 currently recruiting?
Yes, NCT06982300 is actively recruiting participants. Contact the research team at s.oosting@umcg.nl for enrollment information.
Where is the NCT06982300 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT06982300 clinical trial?
NCT06982300 is sponsored by University Medical Center Groningen. The principal investigator is Sjoukje F. Oosting, MD, PhD at University Medical Center Groningen, Dept. of Medical Oncology, Hanzeplein 1, 9713 GZ Groningen, The Netherlands. The trial plans to enroll 10 participants.