RecruitingPhase 1Phase 2NCT06982300

SSTR2 Imaging With [68Ga]Ga-DOTA-TOC PET/CT in NPC

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.

Sponsor

University Medical Center Groningen

Enrollment

10 participants

Start Date

Sep 25, 2025

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Carcinoma (NPC)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a specialized PET/CT scan with a tracer called [68Ga]Ga-DOTA-TOC to image a protein called SSTR2 in people with nasopharyngeal carcinoma (NPC — a cancer in the upper part of the throat behind the nose). Researchers want to see if this imaging technique can predict treatment response or help guide therapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage IB to IVA nasopharyngeal carcinoma that is EBV-positive (Epstein-Barr virus related) - You are planned to receive induction chemotherapy or chemoradiation therapy - You have tumor tissue available or are willing to have a biopsy **You may NOT be eligible if...** - You have previously received chemotherapy or radiation for NPC - You are unable to lie flat for 25 minutes (needed for the scan) - You have other significant health conditions that might interfere with the study results - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHER[68Ga]Ga-DOTA-TOC PET imaging

Patients will undergo \[68Ga\]Ga-DOTA-TOC PET imaging before and 3 weeks after start of standard of care treatment with induction chemotherapy or CRT, unless the baseline scan shows no tracer uptake in the tumor, in that case the scan will not be repeated. Patients will receive 120 MBq \[68Ga\]Ga-DOTA-TOC intravenously and will be scanned up to 20 minutes, 60 minutes after tracer injection, after acquisition of a low dose CT for attenuation correction. The investigators will use archival tissue of the diagnostic biopsy for SSTR2 staining. If there is not sufficient tumor tissue available, a new biopsy will be performed after the baseline PET scan. Blood samples will be drawn before the start, during and after finishing therapy at 3 or 4 different time points, depending on the treatment schedule.

Locations(1)

University Medical Center Groningen

Groningen, Netherlands

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NCT06982300

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