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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04147494
• Other study ID #: 19-000756
• Secondary ID: NCI-2019-07265
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 5, 2019
• Est. completion date: October 17, 2031

Study information

• Verified date: April 2024
• Source: Jonsson Comprehensive Cancer Center
• Contact: Ethan Lam
• Phone: 310 206-7372
• Email: clam[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable). 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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Carcinoma, Renal Cell
• Colon Carcinoma
• Esophageal Carcinoma
• Esophageal Neoplasms
• Gastric Carcinoma
• Head and Neck Carcinoma
• Kidney Carcinoma
• Kidney Neoplasms
• Lung Carcinoma
• Ovarian Carcinoma
• Pancreatic Carcinoma
• Pancreatic Neoplasms
• Solid Neoplasm
• Stomach Neoplasms
• Uterine Corpus Cancer

Intervention

Procedure:
• Computed Tomography
Undergo PET/CT scan

Radiation:
• Gallium Ga 68 FAPi-46
Given IV
• Gallium Ga 68-labeled PSMA-11
Given IV

Procedure:
• Positron Emission Tomography
Undergo PET/CT scan

Radiation:
• 18F-FDG
Given IV

Locations

Country	Name	City	State
United States	Ethan Lam	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Society of Nuclear Medecine and Molecular Imaging

Country where clinical trial is conducted

United States, 

Outcome

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