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PET Biodistribution Study of 68Ga-PSMA-11 and 68Ga-FAPI-46

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 : January 14, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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Brief Summary:
The tumor stroma supports tumor growth, promotes tumor aggressiveness and metastatic potential. Stroma targeting approaches have become an attractive goal in research and industry. Braking the tumor stroma barrier may make tumor cells more accessible for pharmacologic, immunologic, radioactive or cell-based therapies.

Condition or disease Intervention/treatment Phase
Breast Cancer Colon Cancer Esophageal Cancer Gastric Cancer Head and Neck Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer Renal Cancer Uterus Cancer Drug: 68GA-PSMA, 68GA-FAPi Early Phase 1

Detailed Description:

The tumor stroma supports tumor growth, promotes tumor aggressiveness and metastatic potential. Stroma targeting approaches have become an attractive goal in research and industry. Braking the tumor stroma barrier may make tumor cells more accessible for pharmacologic, immunologic, radioactive or cell-based therapies.

Prostate Specific Membrane Antigen (PSMA) protein expression is not specific for prostate cancer and has been observed in many other cancers. It is also expressed by endothelium of tumor stromal neovasculature (NV) cells. PSMA expressing NV cells represent a potential therapeutic and imaging stromal target.

Cancer associated fibroblasts (CAF) can constitute >90% of tumor stroma and thus represent another potentially relevant stromal target. They express the Fibroblast Activation Protein (FAP).

The investigators hypothesize that FAP-positive CAFs represent a new therapeutic and imaging stroma target across many cancers.

PET (positron emission tomography) imaging of PSMA and FAP is now feasible using 2 new nuclear probes labelled with the positron-emitter gallium-68:

  • One is called 68Ga-FAPI-46 and targets the cancer associated fibroblasts via FAP (fibroblast activated protein).
  • The other one is called 68Ga-PSMA-11 and targets the cell surface protein PSMA (prostate specific membrane antigen) which is expressed by the NV cells of non-prostate cancers.

Patients with various malignancies who are scheduled for surgery of their cancer (primary tumor and/or metastasis) will be enrolled and will undergo one 68Ga-FAPI-46 and one 68Ga-PSMA-11 PET/CT scan on 2 separate days before the surgery.

The tracer uptake will be quantified in the tumors and other organs (biodistribution = repartition of the radioactive tracer in the body) by PET imaging and will be correlated to histopathology from excised tumors.

The aim is to evaluate whether 68Ga-FAPi-46 and 68Ga-PSMA-11 tumor biodistribution reflects geography, extent and degree of tumor FAP and PSMA expression determined in excised cancer tissue. The team will conduct histopathological and immuno-histochemical analysis to quantify tumor cell vs. stroma proportions and target expression, respectively. The investigators hypothesize that PET image biodistribution will reflect stromal tumor content and that CAF content and degree of NV will be reflected on 68Ga-FAPi-46 and 68Ga-PSMA-11 PET/CT images respectively.

The enrolled patients will thus be studied under the same IRB approved study protocol but under 2 different regulatory mechanism (IND for 68Ga-PSMA-11, RDRC for 68Ga-FAPi-46).

A total of 30 patients will undergo imaging with both PET probes.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The primary objective of this study is to evaluate the biodistribution of 68Ga-PSMA and 68Ga-FAPi in patients who have non-prostate cancers and are scheduled for tumor resection. The tumor biodistribution will be validated by histopathology from excised tumors.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: PET Biodistribution Study of 68Ga-PSMA-11 and 68Ga-FAPI-46 in Patients With Non-prostate Cancers: an Exploratory Study With Histopathology Validation
Actual Study Start Date : November 5, 2019
Estimated Primary Completion Date : October 31, 2030
Estimated Study Completion Date : October 2031

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PET Biodistribution of 68Ga-PSMA, 68Ga-FAPi

Experimental: Diagnostic

Patients will undergo one 68Ga-FAPI-46 and one 68Ga-PSMA-11 PET/CT scan.

PET (positron emission tomography) imaging of Prostate Specific Membrane Antigen (PSMA) and Fibroblast Activation Protein (FAP) using 2 new nuclear probes labelled with the positron-emitter gallium-68:

  • One is called 68Ga-FAPI-46 and targets the cancer associated fibroblasts via FAP (fibroblast activated protein).
  • The other one is called 68Ga-PSMA-11 and targets the cell surface protein PSMA (prostate specific membrane antigen) which is expressed by the NV cells of non-prostate cancers.

Patients with various malignancies who are scheduled for surgery of their cancer (primary tumor and/or metastasis) will be enrolled and will undergo one 68Ga-FAPI-46 and one 68Ga-PSMA-11 PET/CT scan on 2 separate days before the surgery.

 Drug: 68GA-PSMA, 68GA-FAPi
Tracer biodistribution of 68Ga-PSMA, 68Ga-FAPi evaluated by Computer Tomography


Outcome Measures
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Primary Outcome Measures :
  1. To define and document the biodistribution of 68Ga-FAPi-46 and 68Ga-PSMA-11 in normal and cancer tissues of patients with various non-prostate malignancies. [ Time Frame: Time Frame: 60 minutes after tracer injection ]

    To quantify tumor tissue and normal background organs 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: Time Frame: from date of imaging to date of surgery (range 1-60 days) ]

    To correlate PET imaging signal with FAP and 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: 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
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Ages Eligible for Study:   56 Years to 81 Years   (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.
  • Patients are ≥ 18 years old at the time of the radiotracer administration.
  • 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 judgement of the investigator, might interfere with the collection of high quality data

Contacts and Locations
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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
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Contact: Stephanie Lira 310 206-7372 StephanieLira@mednet.ucla.edu
Contact: Kiara Booker Adame 310-206-7372 KMBooker@mednet.ucla.edu

Locations
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United States, California
University of California at Los Angeles (UCLA) Recruiting
Los Angeles, California, United States, 90024
Contact: Soosan Roodbari    310-794-1596    SROODBARI@MEDNET.UCLA.EDU   
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jeremie Calais, MD Health Science Clinical Assistant Professor
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04147494    
Other Study ID Numbers: 19-000756
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Neoplasms
Uterine Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Urologic Neoplasms
Kidney Diseases
 Urologic Diseases
Uterine Diseases
Edetic Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action