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Imaging of Solid Tumors Using 68Ga-FAP-2286

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ClinicalTrials.gov Identifier: NCT04621435
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
Clovis Oncology, Inc.
Information provided by (Responsible Party):
Thomas Hope, University of California, San Francisco

Brief Summary:
This is a single arm prospective trial that evaluates the ability of a novel imaging agent gallium-68 labelled (68Ga-) FAP-2286 (68Ga-FAP-2286) to detect metastatic cancer in participants with solid tumors using 68Ga-FAP-2286 tracer. FAP-2286 is a peptidomimetic molecule that that binds to Fibroblast Activation Protein (FAP). FAP is a transmembrane protein expressed on cancer-associated fibroblasts, and has been shown to be present on a number of solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumors, Adult Metastatic Cancer Drug: Gallium-68 labelled (68Ga-) FAP-2286 Procedure: Positron Emission Tomography (PET) imaging Phase 1

Detailed Description:

Initially the investigator(s) will focus on imaging breast, pancreas, sarcoma, prostate cancer, bladder cancer, colon cancer, and head and neck cancer.

STUDY AIMS

  1. determine the dosimetry for gallium-68 labelled (68Ga-) FAP-2286,
  2. evaluate the uptake and retention of radiotracer in a variety of solid tumors with FAP-2286, and
  3. evaluate the ability of FAP-2286 to detect metastatic disease.

PRIMARY OBJECTIVES

  1. All cohorts: Safety of 68Ga-FAP-2286
  2. Cohort 1: determine the organ dosimetry of 68Ga-FAP-2286
  3. Cohort 2: determine the feasibility of detecting tumor uptake using 68Ga-FAP-2286
  4. Cohort 3: determine the feasibility of detecting metastatic disease using 68Ga-FAP-2286

EXPLORATORY OBJECTIVES

  1. Correlation of 68Ga-FAP-2286 uptake with FAP expression determined by immunohistochemistry.
  2. Compare 68Ga-FAP-2286 scan results to archival Fluorodeoxyglucose (FDG)-PET images.
  3. Compare biodistribution of 68Ga-FAP-2286 in normal organs and blood pool based on renal function.
  4. Determine impact of administered dose of 68Ga-FAP-2286 on image quality.

A repeat 68Ga-FAP-2286 PET may be obtained after initiation of subsequent treatment in order to evaluate changes in PET uptake due to treatment effect. Patients will be followed for up to 3 days after the injection of 68Ga-FAP-2286 for evaluation of adverse events.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging of Solid Tumors Using 68Ga-FAP-2286
Actual Study Start Date : December 14, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dosimetry population (Cohort 1)
PET imaging will begin 30 +/-10 minutes, 60 +/-15 minutes and 120 +/-20 minutes after injection. Contrast may be administered if clinically indicated.
Drug: Gallium-68 labelled (68Ga-) FAP-2286
The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
Other Name: 68Ga-FAP-2286

Procedure: Positron Emission Tomography (PET) imaging
Participants will be scanned for approximately 30 to 45 minutes
Other Name: PET

Experimental: Participants with metastatic disease (Cohort 2)
Participants with metastatic disease will have PET imaging 50-100 minutes after injection of 68Ga-FAP-2286. Contrast may be administered if clinically indicated.
Drug: Gallium-68 labelled (68Ga-) FAP-2286
The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
Other Name: 68Ga-FAP-2286

Procedure: Positron Emission Tomography (PET) imaging
Participants will be scanned for approximately 30 to 45 minutes
Other Name: PET

Experimental: Participants without metastatic disease (Cohort 3)
Participants without metastatic disease will have PET imaging 50-100 minutes after injection of 68Ga-FAP-2286. Contrast may be administered if if clinically indicated.
Drug: Gallium-68 labelled (68Ga-) FAP-2286
The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
Other Name: 68Ga-FAP-2286

Procedure: Positron Emission Tomography (PET) imaging
Participants will be scanned for approximately 30 to 45 minutes
Other Name: PET




Primary Outcome Measures :
  1. Count of participants with treatment emergent adverse events [ Time Frame: Up to 3 days ]
    The frequency and severity of treatment emergent adverse events following 68Ga-FAP-2286 injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

  2. Proportion of radiation-absorbed doses of 68Ga-FAP-2286 (Cohort 1 only) [ Time Frame: Up to 3 days ]
    Volumes of interest will be drawn around regions identified on the scans, including the liver, spleen, kidneys, urinary bladder, the central sacrum (for hematopoietic marrow) and whole body. Data will be fitted using the Simulation, Analysis, and Modeling Software II (SAAM II) software. Time integrals of activity will be entered into the Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA/EXM) software, using the reference adult model. The results from all patients enrolled will be combined to allow the calculation of mean, standard deviation (SD), and range of radiation-absorbed doses to individual organs

  3. Standardized Uptake Values (SUVs) (Cohort 2 only) [ Time Frame: Up to 3 days ]
    Defined as the maximum Standardized Uptake Value (SUVmax) 1.5 times greater than blood pool

  4. Tumor-to-background (TBR) Ratio (Cohort 2 only) [ Time Frame: Up to 3 days ]
    TBR ratios will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity. The median and range of the measured TBRs will be reported across all RECIST measurable lesions as a table broken down by location (organ metastases, nodal metastases and bone metastases).

  5. Sensitivity of 68Ga-FAP-2286 PET compared to conventional imaging (Cohort 3 only) [ Time Frame: Up to 3 days ]
    Conventional imaging will be reviewed in conjunction with the 68Ga-FAP-2286 PET images. Lesions will be characterized as positive on 68Ga-FAP-2286 PET if uptake is greater than 1.5 times higher than mediastinal blood pool and uptake cannot be attributed to physiologic or inflammatory reasons. Conventional imaging will be interpreted as positive by each lesion if the short axis dimension of lymph nodes is greater than 1 centimeter (cm), and organ metastases measure greater than 1 cm in long axis. The gold standard will be the combination of conventional imaging and 68Ga-FAP-2286 PET in combination with clinical follow-up and histopathology (if available). The number of lesions detected by each modality will be compared and sensitivity will be computed. Since this is a proof-of-concept study, it is not powered for the test of agreement. Nevertheless, the agreement will be tested using McNemar's test.

  6. Specificity of 68Ga-FAP-2286 PET compared to conventional imaging (Cohort 3 only) [ Time Frame: Up to 3 days ]
    Conventional imaging will be reviewed in conjunction with the 68Ga-FAP-2286 PET images. Lesions will be characterized as positive on 68Ga-FAP-2286 PET if uptake is greater than 1.5 times higher than mediastinal blood pool and uptake cannot be attributed to physiologic or inflammatory reasons. Conventional imaging will be interpreted as positive by each lesion if the short axis dimension of lymph nodes is greater than 1 centimeter (cm), and organ metastases measure greater than 1 cm in long axis. The gold standard will be the combination of conventional imaging and 68Ga-FAP-2286 PET in combination with clinical follow-up and histopathology (if available). The number of lesions detected by each modality will be compared and specificity will be computed. Since this is a proof-of-concept study, it is not powered for the test of agreement. Nevertheless, the agreement will be tested using McNemar's test.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >= 18 years
  2. Histopathologically confirmed solid tumors in one of the following cohorts:

    a. Cohort 1 (n=5): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases.

    i. Agnostic to tumor type. b. Cohort 2 (n=30): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases.

    i. Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma, castrate resistant prostate cancer, bladder cancer, or colon cancer.

    c. Cohort 3 (n=30): No evidence of metastatic disease as defined as the absence of RECIST 1.1 measurable disease or bone metastases.

    i. Patients can be imaged at initial staging with what is judged by the treating physician to be high risk disease and where the presence of metastatic disease would greatly impact treatment planning and prognosis. Patients may also be imaged after definitive therapy (surgery, chemotherapy or radiation therapy) if in the determination of the treating physician or investigator there is a high risk of disease recurrence that would also impact treatment plan and/or prognosis.

    ii. Pathologically confirmed head and neck cancer or bladder cancer.

  3. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

  1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
  2. Known pregnancy.

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): NCT04621435


Contacts
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Contact: Maya Aslam 877-827-3222 Maya.Aslam@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Maya Aslam    877-827-3222    Maya.Aslam@ucsf.edu   
Contact       cancertrials@ucsf.edu   
Principal Investigator: Thomas Hope, MD         
Sponsors and Collaborators
Thomas Hope
Clovis Oncology, Inc.
Investigators
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Principal Investigator: Thomas Hope, MD University of California, San Francisco
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Responsible Party: Thomas Hope, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04621435    
Other Study ID Numbers: 20929
NCI-2020-11728 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
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
Keywords provided by Thomas Hope, University of California, San Francisco:
PET
68Ga-FAP-2286
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes