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Evaluation of PSMA Antagonist Produced by Two Different Methods

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Completed
CT.gov ID
NCT04685811
Collaborator
National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH)
19
Enrollment
1
Location
1
Arm
6.7
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with metastatic prostate cancer will undergo two protocol 68Ga-PET scans within 24-48 hours with 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator radiotracers. The goal of the study is to evaluate repeatability and equivalence across the different 68Ga-PSMA production methods. This research study is being conducted to assess whether the PET/CT imaging results, as generated from the two different 68Ga production methods, are equivalent.

Condition or Disease Intervention/Treatment Phase
  • Drug: 68Ga-PSMA-cyclotron Versus 68Ga-PSMA-generator
 Phase 1/Phase 2

Detailed Description

Patients with metastatic prostate adenocarcinoma will be enrolled in the study and will undergo two 68Ga-Prostate Specific Membrane Antigen- Positron Emission Tomography (PSMA-PET) scans within 24-48 hours. The difference between the two scans is that the radiotracer used in each scan will be produced with a different method (68Ga-PSMA-cyclotron and 68Ga-PSMA-generator produced). The first scan will occur after a baseline clinical evaluation, which will include a history, physical, and baseline lab draw. After each scan, blood draws will be obtained.

The purpose of this study is to evaluate equivalence of two processes to create 68Ga-HBED-PSMA and compare dosimetry, biodistribution and whole body excretion/ metabolism. Furthermore, the research team will perform dynamic analysis of the PET scans to investigate repeatability of whole-body 68Ga-PSMA-generator Ki Patlak imaging against that of conventional whole-body 68Ga-PSMA- SUV imaging and evaluate equivalence of whole-body 68Ga-PSMA Ki Patlak imaging between the two processes to create 68Ga-HBED-PSMA (68GA-PSMA-cyclotron vs. 68Ga-PSMA-generator). Patients will afterwards receive standard of care treatment and follow up imaging.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of a 68Ga Small Molecule PSMA Antagonist Produced by Two Different Methods
Actual Study Start Date :
Dec 9, 2020
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga-PSMA-cyclotron Vesus 68Ga-PSMA-generator

Patients with metastatic prostate cancer will undergo two protocol 68Ga-PET scans within 24-48 hours with 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator radiotracers.

Drug: 68Ga-PSMA-cyclotron Versus 68Ga-PSMA-generator
68Ga-PSMA-cyclotron and 68Ga-PSMA-generator; single dose each, approximately 100-300 mBq.
Other Names:
  • Prostate specific membrane antigen imaging (PSMA)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate Equivalence between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator (wCV) [24 to 48 hours]

      The correlation-coefficient for SUVmax and SUVmean of the same Regions of Interest (ROI) in 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator will be calculated. The SUVmean and SUVmax obtained from both scans for each Region of Interest will then be analyzed to determine the within subject coefficient of variation (wCV) value as measured by the Bland Altman analysis.

    2. Evaluate Equivalence between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator (RC) [24 to 48 hours]

      The correlation-coefficient for SUVmax and SUVmean of the same Regions of Interest (ROI) in 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator will be calculated. The SUVmean and SUVmax obtained from both scans for each Region of Interest will then be analyzed to determine the repeatability coefficient (RC) as measured by the Bland Altman analysis.

    Secondary Outcome Measures

    1. Compare Dosimetry between 68GA-PSMA-cyclotron vs. 68Ga-PSMA-generator [24 to 48 hours]

      Lesional dosimetry will be performed on the same patients having both the 68GA-PSMA-cyclotron and 68Ga-PSMA-generator to further estimate their equivalence at various pre-determined timepoints. wCV unit will be used to compare these lesions.

    2. Compare Bio-Distribution between 68GA-PSMA-cyclotron vs. 68Ga-PSMA-generator [24 to 48 hours]

      The biodistribution of 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator will be evaluated by measuring the radioactivity concentration in various organs of interest. Based on the SUVmean and SUVmax, the RC unit will be used to compare these scans.

    3. Compare Whole Body Excretion/Metabolism between 68GA-PSMA-cyclotron vs. 68Ga-PSMA-generator [24 to 48 hours]

      The presence of metabolites and the excretion of radionuclides will be calculated by measuring the amount of 68Ga and 66Ga (mCi) in the blood at 0, 5, 15, 30, and 60 minutes after injection, as well as post-imaging.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Subjects must meet all of the following criteria to be enrolled in this study:

    • Aged 21 years or older and below 80 years of age

    • Signed written informed consent and willingness to comply with protocol requirements

    • Histologically confirmed diagnosis of metastatic prostate cancer

    • Staging imaging exam confirming metastatic disease, e.g. total body MRI, or CT chest/abdomen/pelvis, 99mTc bone scan, NaF PET

    Exclusion Criteria:

    • Laboratory values:

    • Serum creatinine >2.5 mg/dL

    • AST (SGOT) >2.5x ULN

    • Bilirubin (total) >1.5x ULN

    • Serum calcium >11 mg/dL

    • Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject.

    • Presence of serious systemic illness, including: uncontrolled inter-current infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might limit compliance with study requirements.

    • Other severe acute or chronic medical condition(s) or laboratory abnormality(ies) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and in the judgment of the investigator, would make the patient inappropriate for entry into this study.

    • Inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Weill Cornell Medicine New York New York United States 10021

    Sponsors and Collaborators

    • Weill Medical College of Cornell University
    • National Institutes of Health (NIH)
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Joseph R Osborne, M.D., Weill Medical College of Cornell University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT04685811
    Other Study ID Numbers:
    • 19-11021092
    • 7R01CA207645-03
    First Posted:
    Dec 28, 2020
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Weill Medical College of Cornell University
    Prostate Cancer
    Additional relevant MeSH terms:
    Adenocarcinoma
    Gallium 68 PSMA-11

    Study Results

    No Results Posted as of Feb 3, 2022