Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer
NCT ID: NCT03444844
Last Updated: 2022-05-02
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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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2018-05-10
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Biochemical recurrent prostate cancer
IV injection of 2 - 6 mCi of Ga-68 P16-093 followed by whole body PET/CT scanning (pelvis to shoulders) for \~ 60 min (\~150 min for first 10 patients/dosimetry) starting immediately after injection.
A contrast CT scan follows PET scan.
Ga-68 P16-093 PET/CT scan
IV injection followed by PET/CT scanning
Intermediate/High Risk primary prostate cancer
IV injection of 2 - 6 mCi of Ga-68 P16-093 followed by list mode PET/CT scanning using a fixed FOV including the pelvis area for \~ 50 min.
Ga-68 P16-093 PET/CT scan
IV injection followed by PET/CT scanning
Interventions
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Ga-68 P16-093 PET/CT scan
IV injection followed by PET/CT scanning
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prostate cancer patients presenting with rising PSA after radical prostatectomy for treatment if primary disease.
* PSA ≥ 0.2 ng/mL
* Patients must give informed consent for the research study, and agree to allow investigator access to clinical results following treatment plan implementation such as description of the treatment plan and PSA values following implementation of treatment plan as part of standard care, typically determined 3-4 months after treatment.
* Male ≥ 18 years of age
* Histologically confirmed prostate cancer with following Gleason scoring at biopsy:
* Gleason ≥ 4+3 OR
* Gleason 3+4 with \>30% pattern 4 or ≥3 cores positive
* Scheduled for radical prostatectomy (expected to occur within 60-days of scanning)
* Patients must give informed consent for the research study, and agree to allow investigator access to the clinical results such as SOC imaging (mpMRI, e.g.) for surgical planning if done, or biopsy data following prostatectomy including lymph node dissection biopsy data, if available.
Exclusion Criteria
* Patient is unable to tolerate remaining still on the bed of the PET camera, due to physical limitations or claustrophobia.
* Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Clinical Investigators, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study
18 Years
MALE
No
Sponsors
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Indiana University
OTHER
Five Eleven Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Green, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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IU-1711061247
Identifier Type: -
Identifier Source: org_study_id
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