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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520689-23-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [68Ga]Ga-DOTA-TOC PET imaging | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| [68Ga]Ga-DOTA-TOC uptake in the primary tumor and lymph node metastase | Determine [68Ga]Ga-DOTA-TOC uptake in the primary tumor and lymph node metastases in patients with EBV-related NPC, at baseline and early after the start of curative intent treatment, consisting of CRT with or without induction chemotherapy. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Sjoukje F. Oosting, MD, PhD | University Medical Center Groningen, Dept. of Medical Oncology, Hanzeplein 1, 9713 GZ Groningen, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Recruiting | Groningen | 9713 GZ | Netherlands |
The decision whether or not to share IPD will be made after consultation of the PI.
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| [68Ga]Ga-DOTA-TOC distribution | Normal tissue and organ distribution of [68Ga]Ga-DOTA-TOC in NPC patients defined by standard uptake value (SUV) | 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 | Comparison of tumor [68Ga]Ga-DOTA-TOC uptake on the baseline study PET scan with SSTR2 expression on the tumor biopsy, determined by IHC. | The day of the first study scan within one week before the start of treatment |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |