SSTR2 Imaging With [68Ga]Ga-DOTA-TOC PET/CT in NPC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [68Ga]Ga-DOTA-TOC PET imaging.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma (NPC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Other [68Ga]Ga-DOTA-TOC PET imaging
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 tissu
Primary outcome measures
- Feasibility of assessing tumor SSTR2 expression [Time frame: 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 outcome measures (3)
- [68Ga]Ga-DOTA-TOC uptake in the primary tumor and lymph node metastase [Time frame: 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 [Time frame: 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 [Time frame: The day of the first study scan within one week before the start of treatment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Netherlands · 1 center
- University Medical Center Groningen — Groningen
Identifiers
NCT: NCT06982300 · 21477 · 2025-520689-23-00