Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
191 participants
INTERVENTIONAL
2020-12-14
2026-12-31
Brief Summary
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Detailed Description
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STUDY AIMS
1. Determine the dosimetry for gallium-68 labelled (68Ga-) and 64Cu- FAP-2286.
2. Evaluate the uptake and retention of radiotracer in a variety of solid tumors with FAP-2286.
3. Evaluate the ability of FAP-2286 to detect metastatic disease.
PRIMARY OBJECTIVES
1. All cohorts: Safety of 68Ga- and 64Cu-FAP-2286.
2. Cohort 1a: determine the organ dosimetry of 68Ga-FAP-2286.
3. Cohort 1b: determine the organ dosimetry of 64Cu-FAP-2286.
4. Cohort 2: To assess the feasibility of detecting tumor uptake using FAP-2286.
5. Cohort 3: To determine the feasibility of detecting metastatic disease using FAP-2286.
EXPLORATORY OBJECTIVES
1. To detect the sensitivity of FAP-2286 PET compared to conventional imaging for the detection of metastatic disease, and when available sensitivity compared to Fluorodeoxyglucose (FDG) PET (FDG-PET).
2. Correlation of FAP-2286 uptake with FAP expression determined by immunohistochemistry.
3. Compare biodistribution of 68Ga-FAP-2286 and 64Cu-FAP-2286 in normal organs and blood pool based on renal function.
4. Determine impact of administered dose of FAP-2286 on image quality.
5. Compare the feasibility of detecting tumor uptake using 68Ga-FAP-2286 and 64Cu-FAP-2286
A repeat radiolabeled FAP-2286 PET may be obtained after initiation of subsequent treatment in order to evaluate changes in PET uptake due to treatment effect. Participants will be followed through the day of the last injection of radiolabeled FAP-2286 for evaluation of adverse events.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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CLOSED - 68Ga-Dosimetry population (Cohort 1a)
PET imaging will begin 30 +/-10 minutes, 60 +/-15 minutes and 120 +/-20 minutes after injection of 68Ga-FAP-2286. Contrast may be administered if clinically indicated.
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
Positron Emission Tomography (PET) imaging
Participants will be scanned for approximately 30 to 45 minutes
CLOSED - 64Cu-Dosimetry population (Cohort 1b)
PET imaging will begin 60±15 minutes, 240±30 minutes after injection, and a second PET imaging will be performed 24±2 hours after initial injection of 64Cu-FAP-2286. Contrast may be administered if clinically indicated.
Positron Emission Tomography (PET) imaging
Participants will be scanned for approximately 30 to 45 minutes
Copper-64 labeled (64Cu-) FAP-2286
The dose will be 3.5 to 5.5 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
Participants with metastatic disease (Cohort 2)
Participants with metastatic disease will have PET imaging 50-100 minutes after injection of 68Ga- or 64Cu- FAP-2286. Contrast may be administered if clinically indicated.
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
Positron Emission Tomography (PET) imaging
Participants will be scanned for approximately 30 to 45 minutes
Copper-64 labeled (64Cu-) FAP-2286
The dose will be 3.5 to 5.5 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
Participants without metastatic disease (Cohort 3)
Participants without metastatic disease will have PET imaging 50-100 minutes after injection of 68Ga- or 64Cu- FAP-2286. Contrast may be administered if if clinically indicated.
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
Positron Emission Tomography (PET) imaging
Participants will be scanned for approximately 30 to 45 minutes
Copper-64 labeled (64Cu-) FAP-2286
The dose will be 3.5 to 5.5 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
Interventions
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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
Positron Emission Tomography (PET) imaging
Participants will be scanned for approximately 30 to 45 minutes
Copper-64 labeled (64Cu-) FAP-2286
The dose will be 3.5 to 5.5 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histopathologically confirmed solid tumors in one of the following cohorts:
a. Cohort 1 (n=11): measurable disease is not required for this cohort.
i. Agnostic to tumor type.
b. Cohort 2 (n=95): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases. Note: Presence of absence of metastatic disease for eligibility determination will be assessed by reviewing medical records. Screening imaging will not be conducted for this study.
i. Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma, castrate-resistant prostate cancer, bladder cancer, or colon cancer.
ii. Pathologically confirmed cancer other than noted above (basket subgroup, n=10).
c. Cohort 3 (n=85): No evidence of metastatic disease as defined as the absence of RECIST 1.1 measurable disease or bone metastases. Note: Presence of absence of metastatic disease for eligibility determination will be assessed by reviewing medical records. Screening imaging will not be conducted for this study.
i. Participants 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. Participants 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
2. Known pregnancy.
18 Years
ALL
No
Sponsors
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Society of Abdominal Radiology
OTHER
Thomas Hope
OTHER
Responsible Party
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Thomas Hope
Principal Investigator
Principal Investigators
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Thomas Hope, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Maya Aslam
Role: primary
Role: backup
Other Identifiers
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NCI-2020-11728
Identifier Type: REGISTRY
Identifier Source: secondary_id
20929
Identifier Type: -
Identifier Source: org_study_id