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
|
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
Society of Nuclear Medecine and Molecular Imaging
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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.
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Nuclear Scans
Drug Information available for:
Gallium Ga 68 gozetotide
| 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 |
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 [ 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).
Secondary Outcome Measures :
- 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-).
Other Outcome Measures:
- 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
Information from the National Library of Medicine
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 |
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
Information from the National Library of Medicine
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
Contacts
| Contact: Andrea Limon | 310 206-7372 | AndreaLimon@mednet.ucla.edu | |
| Contact: Ethan Lam | 310-206-7372 | eclam@mednet.ucla.edu |
Locations
| 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 | |
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 |
| 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 |
Additional relevant MeSH terms:
|
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 |