Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers (FAPI PET RDRC)

  • STATUS
    Recruiting
  • End date
    Jul 1, 2024
  • participants needed
    30
  • sponsor
    Jonsson Comprehensive Cancer Center
Updated on 21 April 2022
ct scan
cancer
hematologic malignancy
carcinoma
adrenaline
metastasis
pet scan
positron emission tomography
thymus cancer
dotatate
bladder cancer
pet/ct scan
testicular
cholangiocarcinoma
bladder tumor

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.

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 correlation of 68Ga-FAPI-46 biodistribution with 18F-fluodeoxyglucose (FDG), 68Ga-DOTATATE, or 18F-DOPA (FDOPA), depending on the specific indication.

OUTLINE

Patients receive 68Ga-FAPi-46 intravenously (IV) then 20-90 minutes later undergo PET/computed tomography (CT).

Details
Condition 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
Treatment computed tomography, positron emission tomography, Gallium Ga 68 FAPi-46
Clinical Study IdentifierNCT04459273
SponsorJonsson Comprehensive Cancer Center
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with the following cancer types
Brain cancer
Bladder cancer
Urothelial cancer
Testicular cancer
Skin cancer
Thyroid cancer
Hepatocellular carcinoma
Cholangiocarcinoma
Thymus cancer
Pleural cancer
Cervical cancer
Adrenal cancer
Neuroendocrine tumors
Hematologic cancer
Patients who underwent a staging PET/CT scan within 3 months of enrollment (with any
Patients who are scheduled to undergo surgical resection or tissue biopsy of the primary tumor and/or metastasis
PET tracer related to the indication including FDG, DOTATATE, FDOPA)
Patient can provide written informed consent
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 PET/CT and the investigational FAPI PET/CT
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