SSTR2 PET/CT imaging with 68Ga-DOTA-TOC for nasopharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.