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

University Medical Center Groningen (UMCG)

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Nasopharyngeal Carcinoma (NPC)

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06982300

21477

2025-520689-23-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.