Clinical trial NCT06982300: SSTR2 Imaging With [68Ga]Ga-DOTA-TOC PET/CT in NPC
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Nasopharyngeal Carcinoma (NPC)
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of assessing tumor SSTR2 expression
timeFrame: 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:
measure: [68Ga]Ga-DOTA-TOC uptake in the primary tumor and lymph node metastase
timeFrame: 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
measure: [68Ga]Ga-DOTA-TOC distribution
timeFrame: 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
measure: Comparison [68Ga]Ga-DOTA-TOC uptake with SSTR expression
timeFrame: The day of the first study scan within one week before the start of treatment
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen, Dept. of Medical Oncology, Hanzeplein 1, 9713 GZ Groningen, The Netherlands
name: Sjoukje F. Oosting, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: