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

Jonsson Comprehensive Cancer Center

Status and phase

Enrolling

Phase 1

Conditions

Thyroid Gland Carcinoma

Malignant Brain Neoplasm

Malignant Thymus Neoplasm

Malignant Pleural Neoplasm

Urothelial Carcinoma

Bladder Carcinoma

Cholangiocarcinoma

Malignant Solid Neoplasm

Cervical Carcinoma

Malignant Skin Neoplasm

Hematopoietic and Lymphoid Cell Neoplasm

Malignant Adrenal Gland Neoplasm

Cancer of Unknown Primary Site

Hepatocellular Carcinoma

Neuroendocrine Neoplasm

Malignant Testicular Neoplasm

Treatments

Radiation: 18F-FDG

Drug: Gallium Ga 68 FAPi-46

Procedure: Computed Tomography

Procedure: Positron Emission Tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT04459273

NCI-2020-03766 (Registry Identifier)

20-000630

Details and patient eligibility

About

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.

Full 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).

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
- Cancer of Unkown Primary
Patients who are scheduled to undergo surgical resection or tissue biopsy 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 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
Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data