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

NCT06982300 | Recruiting Phase 1

• 2 other identifiers: 214772025-520689-23-00
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma (NPC)

Outcome Measures

Primary Outcomes (1)

• Feasibility of assessing tumor SSTR2 expression

  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.

  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

Secondary Outcomes (3)

• [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

• [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

• Comparison [68Ga]Ga-DOTA-TOC uptake with SSTR expression

  The day of the first study scan within one week before the start of treatment

Study Arms (1)

[68Ga]Ga-DOTA-TOC PET imaging

EXPERIMENTAL

Other: [68Ga]Ga-DOTA-TOC PET imaging

Interventions

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

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.

[68Ga]Ga-DOTA-TOC PET imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Sjoukje F. Oosting, MD, PhD

  University Medical Center Groningen, Dept. of Medical Oncology, Hanzeplein 1, 9713 GZ Groningen, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sjoukje F. Oosting, MD, PhD

CONTACT

+31 50 3612821; s.oosting@umcg.nl

Fleur van Doorn, MD

CONTACT

+31 50 361 2821; f.l.van.doorn@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 21, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

NL (1)