Fludeoxyglucose (18F) for Breast cancer|Neuroendocrine neoplasm|Lymphoma|Sarcoma

Inclusion criteria

• {"criterion_text":"- Diagnosed with one of the following cancers: breast cancer, neuroendocrine neoplasm, lymphoma or sarcoma with a tumor size of at least 1.5 cm."}

Exclusion criteria

• {"criterion_text":"- Pregnancy"}
• {"criterion_text":"- Breast-feeding"}
• {"criterion_text":"- Weighs more 140 kg and/or with abdominal circumference exceeding the gantry of the PET/MR coils"}
• {"criterion_text":"- History of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FDG or pyruvate"}
• {"criterion_text":"- Unable to lie in the PET/MR scanner for up to 90 minutes"}
• {"criterion_text":"- MR contraindications: Pace-maker, metal implantations within the past 6 weeks, non-MR compatible implants, claustrophobia"}

Primary endpoints

• {"endpoint_text":"- Quantification of tumor [1-13C]Pyruvate to [1-13C]Lactate conversion measured through dynamic conversion factors and signal ratios.","definition_or_measurement_approach":"Measured through dynamic conversion factors and signal ratios (as stated)."}
• {"endpoint_text":"- Quantification of tumor uptake of 18-Flouro-deoxy-glucose measured as dynamic glucose influx (Ki) and static standardized uptake values (SUV).","definition_or_measurement_approach":"Measured as dynamic glucose influx (Ki) and static standardized uptake values (SUV) (as stated)."}

Secondary endpoints

• {"endpoint_text":"- Correlation between tumor 18-Flouro-deoxy-glucose uptakes and [1- 13C]Pyruvate to [1-13C]Lactate conversion and ex-vivo non-quantitative and quantitative expression of biomarkers involved in intracellular metabolism.","definition_or_measurement_approach":"Correlation of imaging metrics (18F-FDG uptake and [1-13C]Pyruvate→[1-13C]Lactate conversion) with ex-vivo biomarker expression measured by methods including immunohistochemistry, ELISA, qPCR and microRNA (as described in secondary objectives)."}

Denmark

Earliest CTIS Part Ii Submission Date

14-08-2024

Latest Decision Or Authorization Date

28-08-2024

Processing Time Days

14

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties: code 1 (as listed in CTIS thirdParties entry); contact email: gcp-enheden.bispebjerg-frederiksberg-hospitaler@regionh.dk","organisation_type":"Hospital/Clinic/Other health care facility"}