SSTR2 PET/CT imaging with 68Ga-DOTA-TOC for nasopharyngeal cancer
Towards Improved Therapy Selection and Targeted Treatment for Nasopharyngeal Carcinoma: a Proof-of-concept Pilot Study for Somatostatin Receptor 2 Imaging With [68Ga]Ga-DOTA-TOC PET/CT.
PHASE1; PHASE2 · University Medical Center Groningen · NCT06982300
We will test whether 68Ga‑DOTA‑TOC PET/CT scans can detect SSTR2 in adults with EBV‑positive nasopharyngeal cancer before and three weeks after starting chemotherapy or chemoradiotherapy.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06982300 on ClinicalTrials.gov |
What this trial studies
This single-center, investigator-initiated Phase 1/2 trial uses 68Ga‑DOTA‑TOC PET/CT to image somatostatin receptor 2 (SSTR2) expression in patients with EBV‑positive nasopharyngeal carcinoma prior to treatment and three weeks after treatment begins. Archival diagnostic tumor tissue (or a new biopsy) will undergo SSTR2 immunohistochemistry to correlate tissue expression with PET signal. Blood samples will be collected at baseline, three weeks, after completion of induction chemotherapy if given, and after completion of chemoradiotherapy to explore peripheral biomarkers and treatment-related changes. Imaging and tissue correlation will test feasibility and concordance of SSTR2 PET as a biomarker for this patient population.
Who should consider this trial
Good fit: Adults (≥18) with EBV-positive stage IB–IVA nasopharyngeal carcinoma who are treatment-naïve, planned for induction chemotherapy or concurrent chemoradiotherapy, and have archival tumor tissue or agree to biopsy are ideal candidates.
Not a fit: Patients who have received prior chemotherapy or radiotherapy for NPC, those with SSTR2-negative tumors, or those with comorbidities that confound imaging or safety are unlikely to benefit from the imaging approach.
Why it matters
Potential benefit: If successful, the imaging could help identify SSTR2-positive tumors and guide selection for SSTR-targeted imaging or therapies, improving personalized care for NPC patients.
How similar studies have performed: 68Ga‑DOTA‑TOC PET/CT is well established for imaging somatostatin receptors in neuroendocrine tumors, but its application in EBV‑related nasopharyngeal carcinoma is novel and has limited prior data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Sjoukje F. Oosting, MD, PhD — University Medical Center Groningen, Dept. of Medical Oncology, Hanzeplein 1, 9713 GZ Groningen, The Netherlands
- Study coordinator: Sjoukje F. Oosting, MD, PhD
- Email: s.oosting@umcg.nl
- Phone: +31 50 3612821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nasopharyngeal Carcinoma