Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 4, 2022
Sponsor:
Collaborator:
Society of Nuclear Medecine and Molecular Imaging
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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 Early Phase 1

Detailed 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. 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT scan
  • tomography

Radiation: Gallium Ga 68 FAPi-46
Given IV
Other Names:
  • 68Ga-FAPi-46
  • Gallium-68-FAPi-46

Radiation: Gallium Ga 68-labeled PSMA-11
Given IV
Other Names:
  • (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
  • (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • (68Ga)Glu-urea-Lys(Ahx)-HBED-CC
  • 68Ga-DKFZ-PSMA-11
  • 68Ga-HBED-CC-PSMA
  • 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • 68Ga-PSMA
  • 68Ga-PSMA-11
  • 68Ga-PSMA-HBED-CC
  • [68Ga] Prostate-specific Membrane Antigen 11
  • [68Ga]GaPSMA-11
  • Ga PSMA
  • Ga-68 labeled DKFZ-PSMA-11
  • Ga-68 labeled PSMA-11
  • Gallium Ga 68 PSMA-11
  • Gallium-68 PSMA
  • Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • GaPSMA
  • PSMA-HBED-CC GA-68

Procedure: Positron Emission Tomography
Undergo PET/CT scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • positron emission tomography scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation [ Time Frame: 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:
  1. Additional correlation of biodistribution of standard of care tracer [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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
  • Patient has underlying disease which based on the judgment of the investigator, might interfere with the collection of high quality data
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Erin Shen 310 206-7372 eyshen@mednet.ucla.edu
Contact: Stephanie Lira 310 206-0596 stephanielira@mednet.ucla.edu

Locations
Layout table for location information
United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Erin Shen    310-206-7372    eyshen@mednet.ucla.edu   
Contact: Kiara Booker Adame    310 206-7372    KMBooker@mednet.ucla.edu   
Principal Investigator: Jeremie Calais, MD         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Society of Nuclear Medecine and Molecular Imaging
Investigators
Layout table for investigator information
Principal Investigator: Jeremie Calais, MD UCLA / Jonsson Comprehensive Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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 4, 2022
Last Verified: April 2022

Layout table for additional information
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:
Layout table for 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
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
Urologic Diseases
Edetic Acid
Gallium 68 PSMA-11