Spots Global Cancer Trial Database for Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers

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Trial Identification

Brief Title: Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers

Official Title: PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation

Study ID: NCT04459273

Conditions

Bladder Carcinoma

Cervical Carcinoma

Cholangiocarcinoma

Hematopoietic and Lymphoid Cell Neoplasm

Hepatocellular Carcinoma

Malignant Adrenal Gland Neoplasm

Malignant Brain Neoplasm

Malignant Pleural Neoplasm

Malignant Skin Neoplasm

Malignant Solid Neoplasm

Malignant Testicular Neoplasm

Malignant Thymus Neoplasm

Neuroendocrine Neoplasm

Thyroid Gland Carcinoma

Urothelial Carcinoma

Cancer of Unknown Primary Site

Interventions

Computed Tomography

Gallium Ga 68 FAPi-46

Positron Emission Tomography

18F-FDG

Study Description

Brief Summary: This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors (cancer associated fibroblasts). The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers.

Detailed Description: PRIMARY OBJECTIVE: I. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies. SECONDARY OBJECTIVES: I. To evaluate the degree of 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) imaging as opposed to the amount of FAP in excised cancer tissue. II. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-) EXPERIMENTAL OBJECTIVE: To assess the correlation of 68Ga-FAPI-46 biodistribution with 68Ga-DOTATATE or 18F-DOPA (FDOPA), depending on the specific indication in patients who had them available OUTLINE: Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).