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.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
University Medical Center Groningen
RECRUITING
Groningen
Contact Information
Primary
Sjoukje F. Oosting, MD, PhD
s.oosting@umcg.nl
+31 50 3612821
Backup
Fleur van Doorn, MD
f.l.van.doorn@umcg.nl
+31 50 361 2821
Time Frame
Start Date: 2025-09-25
Estimated Completion Date: 2026-12
Participants
Target number of participants: 10
Treatments
Experimental: [68Ga]Ga-DOTA-TOC PET imaging
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov