Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04147494 |
Recruitment Status :
Recruiting
First Posted : November 1, 2019
Last Update Posted : April 3, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Carcinoma Colon Carcinoma Esophageal Carcinoma Gastric Carcinoma Head and Neck Carcinoma Kidney Carcinoma Lung Carcinoma Ovarian Carcinoma Pancreatic Carcinoma Solid Neoplasm Uterine Corpus Cancer | Procedure: Computed Tomography Radiation: Gallium Ga 68 FAPi-46 Radiation: Gallium Ga 68-labeled PSMA-11 Procedure: Positron Emission Tomography Radiation: 18F-FDG | Early Phase 1 |
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).
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
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 |
Actual Study Start Date : | November 5, 2019 |
Estimated Primary Completion Date : | June 1, 2030 |
Estimated Study Completion Date : | October 17, 2031 |

Arm | Intervention/treatment |
---|---|
Experimental: Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT)
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). 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:
Radiation: 18F-FDG Given IV
Other Name: 18F-fluorodeoxyglucose |
- 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 [ Time Frame: 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).
- 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation [ Time Frame: From date of imaging to date of surgery (range 1-60 days) ]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).
- evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution [ Time Frame: up to 2 years ]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-).
- Additional correlation of biodistribution of standard of care tracer [ Time Frame: 60 minutes after tracer injection ]assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11, if the patient volunteers for optional scan

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147494
Contact: Andrea Limon | 310 206-7372 | AndreaLimon@mednet.ucla.edu | |
Contact: Ethan Lam | 310-206-7372 | eclam@mednet.ucla.edu |
United States, California | |
UCLA / Jonsson Comprehensive Cancer Center | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Andrea Limon 310-206-7372 AndreaLimon@mednet.ucla.edu | |
Contact: Ethan Lam 310 206-7372 eclam@mednet.ucla.edu | |
Principal Investigator: Jeremie Calais, MD |
Principal Investigator: | Jeremie Calais, MD | UCLA / Jonsson Comprehensive Cancer Center |
Responsible Party: | Jonsson Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT04147494 |
Other Study ID Numbers: |
19-000756 NCI-2019-07265 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
First Posted: | November 1, 2019 Key Record Dates |
Last Update Posted: | April 3, 2023 |
Last Verified: | March 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Carcinoma Breast Neoplasms Pancreatic Neoplasms Esophageal Neoplasms Stomach Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Endocrine Gland Neoplasms Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Urogenital Neoplasms Endocrine System Diseases Digestive System Neoplasms Digestive System Diseases Pancreatic Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Esophageal Diseases Gastrointestinal Diseases Stomach Diseases Adenocarcinoma Urologic Neoplasms Kidney Diseases |