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

NCT06982300 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-10-03

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma (NPC)

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.

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Sjoukje F. Oosting, MD, PhD · University Medical Center Groningen, Dept. of Medical Oncology, Hanzeplein 1, 9713 GZ Groningen, The Netherlands

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-25
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06982300 on ClinicalTrials.gov