GALLIUM (68GA) EDOTREOTIDE for Nasopharyngeal carcinoma

Inclusion criteria

• {"criterion_text":"- Stage IB-IVA NPC (AJCC 9th edition), EBV positive determined by Epstein–Barr virus–encoded RNA (EBER)."}
• {"criterion_text":"- Planned treatment with induction chemotherapy or CRT without induction chemotherapy."}
• {"criterion_text":"- Age ≥ 18 years."}
• {"criterion_text":"- Signed informed consent."}
• {"criterion_text":"- Willingness and ability to comply with all protocol required procedures."}
• {"criterion_text":"- Negative serum pregnancy test at screening in women of childbearing potential."}
• {"criterion_text":"- Archival tumor tissue available."}

Exclusion criteria

• {"criterion_text":"- Previous treatment with chemotherapy or radiotherapy for NPC."}
• {"criterion_text":"- Treatment with any investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to [68Ga]Ga-DOTA-TOC injection."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent."}
• {"criterion_text":"- Inability to lie in supine position for 25 minutes."}
• {"criterion_text":"- Patients who are pregnant or breastfeeding."}

Primary endpoints

• {"endpoint_text":"- [68Ga]Ga-DOTA-TOC PET imaging is considered feasible in patients with EBV related NPC if we can visualize and quantify tumor [68Ga]Ga-DOTA-TOC uptake in at least seven out of ten patients and complete repeat imaging in at least six patients.","definition_or_measurement_approach":"Feasibility defined as visualization and quantification of tumor [68Ga]Ga-DOTA-TOC uptake in ≥7/10 patients and completion of repeat imaging in ≥6 patients."}

Secondary endpoints

• {"endpoint_text":"- SUVpeak values of primary tumors and lymph node metastases on the pre-treatment scan.","definition_or_measurement_approach":"Measurement: SUVpeak values measured on the pre-treatment PET scan for primary tumors and lymph node metastases."}
• {"endpoint_text":"- SUVmean values in normal tissues and organs. Healthy lymph nodes will be defined as SUVpeak.","definition_or_measurement_approach":"Measurement: SUVmean in normal tissues and organs; healthy lymph nodes defined using SUVpeak."}
• {"endpoint_text":"- Tumor SSTR2 expression determined by IHC.","definition_or_measurement_approach":"Measurement: Tumor SSTR2 expression assessed by immunohistochemistry (IHC)."}

Netherlands

Earliest CTIS Part Ii Submission Date

03-07-2025

Latest Decision Or Authorization Date

14-07-2025

Processing Time Days

11

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands