68Ga-FAPI-46 (+/- 68Ga-PSMA-11) PET biodistribution in Patients with Non-Prostate Cancers

Status: closed to accrual

This exploratory study uses a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in normal and cancer tissues in patients with various cancer (non-prostate). The research team also want to know whether what they see on PET/CT images represents the tumor tissue being excised from the patient’s body. The research team is also interested to investigate another new imaging technique called PSMA PET/CT. Participants will be invited to undergo a second PET/CT scan, with the PSMA tracer (68Ga-PSMA-11). This is not required but just an option for volunteer patients. Patients can decide to have only the FAPI PET/CT scan. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. 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. PSMA stands for Prostate Specific Membrane Antigen. This name is incorrect as PSMA is also found in many other cancers. The function of PSMA is not well understood but imaging studies have shown that PSMA can be detected with PET in many non-prostate cancers.

Inclusion Criteria

Patients with the following suspected and/or diagnosed cancer types: * Breast cancer * Colon cancer * Esophageal cancer * Gastric cancer * Head and Neck cancer * Lung cancer * Ovarian cancer * Pancreatic cancer * Renal cancer * Uterus cancer
Patients who are scheduled to undergo surgical resection of the primary tumor and/or metastasis
Patients are >= 18 years old at the time of the radiotracer administration
Patient can provide written informed consent
Patient is capable of complying with study procedures
Patient is able to remain still for duration of imaging procedure (up to one hour)

Exclusion Criteria

Patient is pregnant or nursing
Patients with any new cancer therapy between the baseline 18F-FDG PET/CT and the investigational FAPI PET/CT
Patient has underlying disease which based on the judgment of the investigator, might interfere with the collection of high quality data

PRIMARY OBJECTIVE:

I. To define the biodistribution of 68Ga-FAPi-46 and 68Ga-PSMA-11 in normal and cancer tissues of patients with various non-prostate malignancies. The goal is to determine where and to which degree 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulates in normal and cancer tissues.

SECONDARY OBJECTIVES:

I. To evaluate whether 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation observed by positron emission tomography (PET) correlates with the amount of fibroblast activation protein (FAP) in excised cancer tissue as assessed by immunohistochemistry (IHC).

II. To evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-Fludeoxyglucose (FDG) biodistribution (when available) to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-).

III. As an exploratory study aim, will also assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11, if the patient volunteers for optional scan.

OUTLINE:

Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/CT scan over 20-50 minutes. Patients may also receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on a separate day (for volunteer patients only, PSMA PET/CT is optional and not required).

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68Ga-FAPI-46 (+/- 68Ga-PSMA-11) PET biodistribution in Patients with Non-Prostate Cancers

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