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

Phase 1

Not yet recruiting

• Conditions: Nasopharyngeal Carcinoma (NPC)

• Registration Number: NCT06982300
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-25
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-06
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of assessing tumor SSTR2 expression	From the day of the first study scan within one week before the start of treatment to the day of the second study scan three weeks after the start of treatment	Determine feasibility of assessing tumor SSTR2 expression in patients with EBV-associated NPC in a non-endemic region by repeat \[68Ga\]Ga-DOTA-TOC PET imaging.

Secondary Outcome Measures

Name	Time	Method
[68Ga]Ga-DOTA-TOC distribution	From the day of the first study scan within one week before the start of treatment to the day of the second study scan three weeks after the start of treatment	Normal tissue and organ distribution of \[68Ga\]Ga-DOTA-TOC in NPC patients defined by standard uptake value (SUV)
Comparison [68Ga]Ga-DOTA-TOC uptake with SSTR expression	The day of the first study scan within one week before the start of treatment	Comparison of tumor \[68Ga\]Ga-DOTA-TOC uptake on the baseline study PET scan with SSTR2 expression on the tumor biopsy, determined by IHC.
[68Ga]Ga-DOTA-TOC uptake in the primary tumor and lymph node metastase	From the day of the first study scan within one week before the start of treatment to the day of the second study scan three weeks after the start of treatment	Determine \[68Ga\]Ga-DOTA-TOC uptake in the primary tumor and lymph node metastases in patients with EBV-related NPC, at baseline and early after the start of curative intent treatment, consisting of CRT with or without induction chemotherapy.

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands