Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
PRIMARY OBJECTIVE:
- 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:
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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.
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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, 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT) Patients receive 68Ga-FAPi-46 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). |
Procedure: Computed Tomography
Undergo PET/CT scan
Other Names:
Radiation: Gallium Ga 68 FAPi-46
Given IV
Other Names:
Radiation: Gallium Ga 68-labeled PSMA-11
Given IV
Other Names:
Procedure: Positron Emission Tomography
Undergo PET/CT scan
Other Names:
|
Outcome Measures
Primary Outcome Measures
- To define and document 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 [60 minutes after tracer injection]
To quantify tumor tissue and normal background organs positron emission tomography (PET) tracer uptake by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)). The 68Ga-PSMA-11 and 68Ga-FAPI-46 tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax).
Secondary Outcome Measures
- 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation [From date of imaging to date of surgery (range 1-60 days)]
To correlate PET imaging signal with fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) expression by immunohistochemistry (IHC). 68Ga-FAPi-46 and 68Ga-PSMA tumor SUVs will be correlated with FAP and PSMA expression from surgically resected tumors. IHC will be scored with a semi-quantitative scoring system that accounts for staining intensity (0-2, where 0 is negative, 1 is weak, 2 is strong and eq. stands for equivocal). Correlations will be sought using least square regression analysis.
Other Outcome Measures
- Additional correlation of biodistribution of standard of care tracer [60 minutes after tracer injection]
68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 and 18F-fluodeoxyglucose (FDG), if any FDG PET/CT has been performed as standard-of-care.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with the following cancer types:
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Breast cancer
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Colon cancer
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Esophageal cancer
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Gastric cancer
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Head and Neck cancer
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Lung cancer
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Ovarian cancer
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Pancreatic cancer
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Renal cancer
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Uterus cancer
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Patients who are scheduled to undergo surgical resection of the primary tumor and/or metastasis
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Patient can provide written informed consent
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Patient is capable of complying with study procedures
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Patient is able to remain still for duration of imaging procedure (up to one hour)
Exclusion Criteria:
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Patient is pregnant or nursing
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Patient has underlying disease which based on the judgment of the investigator, might interfere with the collection of high quality data
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- Jonsson Comprehensive Cancer Center
- Society of Nuclear Medecine and Molecular Imaging
Investigators
- Principal Investigator: Jeremie Calais, MD, UCLA / Jonsson Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-000756
- NCI-2019-07265