Breast Cancer Clinical Trial

Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues

Summary

This phase I trial studies 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 non-prostate cancer. 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. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, 68Ga-PSMA-11 and 68Ga-FAPi. Because some cancers take up 68Ga-PSMA-11 and/or 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs where it occurs in patient's body. 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. Imaging FAP with PET/CT may in the future provide additional information about various cancers.

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Full Description

PRIMARY OBJECTIVE:

I. To define the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) and gallium Ga 68-labeled PSMA-11 (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) and prostate specific membrane antigen (PSMA) in excised cancer tissue, respectively.

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

EXPERIMENTAL OBJECTIVE:

III. Assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11, if the patient volunteers for optional scan, and 18F-fluodeoxyglucose (FDG), if any FDG PET/computed tomography (CT) has been performed as standard-of-care.

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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Eligibility Criteria

Inclusion Criteria:

Patients with the following 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
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

Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

30

Study ID:

NCT04147494

Recruitment Status:

Recruiting

Sponsor:

Jonsson Comprehensive Cancer Center

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There is 1 Location for this study

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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles California, 90095, United States More Info
Andrea Limon
Contact
310-206-7372
[email protected]
Rejah Marie Alano
Contact
310 206-7372
[email protected]
Jeremie Calais, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

30

Study ID:

NCT04147494

Recruitment Status:

Recruiting

Sponsor:


Jonsson Comprehensive Cancer Center

How clear is this clinincal trial information?

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