Breast Carcinoma Clinical Trial
Official title:
PET Biodistribution Study of 68Ga-PSMA-11 and 68Ga-FAPI-46 in Patients With Non-Prostate Cancers: An Exploratory Biodistribution Study With Histopathology Validation
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 another PET/CT scan, with the PSMA tracer (68Ga-PSMA-11). This is not required but just an option for volunteer patients. Patients who have not received an 18F-FDG PET/CT within one month of enrollment will also undergo an FDG 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, and 18F-FDG (if applicable). 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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 17, 2031 |
Est. primary completion date | June 1, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ethan Lam | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Jonsson Comprehensive Cancer Center | Society of Nuclear Medecine and Molecular Imaging |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Additional correlation of biodistribution of standard of care tracer | assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11, if the patient volunteers for optional scan | 60 minutes after tracer injection | |
Primary | 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 | 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). | 60 minutes after tracer injection | |
Secondary | 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation | To evaluate whether 68Ga-FAPi-46 accumulation observed by PET correlates with the amount of FAP in excised cancer tissue as assessed by immunohistochemistry (IHC). | From date of imaging to date of surgery (range 1-60 days) | |
Secondary | evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution | 2. 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-). | up to 2 years |
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