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Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer

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: NCT03439033
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
This is a study primarily comparing Magnetic Resonance Imaging (MRI) alone to Positron Emission Tomography (PET)/MRI using an experimental tracer, 68Ga-PSMA-HBED-CC, among men with prostate cancer or prostatic cancer recurrence/metastasis. It is hypothesized that this comparison will demonstrate that PET using the tracer, 68Ga-PSMA-HBED-CC, is more sensitive than MRI alone. Potential subjects who cannot undergo MRI may undergo PET/CT instead.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: PET/MRI with Gallium-68 labeled PSMA-HBED-CC Drug: Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC Drug: PET/CT with Gallium-68 labeled PSMA-HBED-CC Phase 2

Detailed Description:
This is a multi-reader methodological study comparing the diagnostic value of 68Ga-PSMA-HBED-CC PET/CT or 68Ga-PSMA-HBED-CC PET/MRI over MRI alone, using histologic confirmation or serial follow-up for up to 2 years as the gold standard for determination of primary prostate cancer or prostatic cancer recurrence/metastasis. It is hypothesized that this will demonstrate the superiority of 68Ga-PSMA-HBED-CC PET to MRI for sensitivity, and the non-inferiority of 68Ga-PSMA-HBED-CC PET to MRI for specificity.This is a paired, case-control design that is appropriate to statistically evaluate the difference in sensitivity and specificity between the two imaging modalities. Therefore, the estimation of population prevalence is not a study objective, and estimation of clinical utility through calculation of positive and negative predictive values is not appropriate. Imaging studies and follow up subject scans will be organized so that a panel of independent readers will evaluate the MRI and PET studies to assess the level of suspicion for prostate cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 322 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects may be assigned to one of three groups, each with a different intervention in terms of either mode or frequency
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Phase 2 Comparison Study of 68Ga-PSMA-HBED-CC Positron Emission Tomography (PET)/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Gallium

Arm Intervention/treatment
Experimental: PET/MRI
PET/MRI with Gallium-68 labeled PSMA-HBED-CC: Subjects will have one visit during which they will undergo a PET/MRI after being injected with the study drug, Gallium-68 labeled PSMA-HBED-CC.
Drug: PET/MRI with Gallium-68 labeled PSMA-HBED-CC
Subjects have one visit, during which they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical

Experimental: Multiple PET/MRI
Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC: Subjects will be invited to participate in two visits within two years, the second being an optional visit. During each visit, subjects will undergo a PET/MRI after being injected with the study drug, Gallium-68 labeled PSMA-HBED-CC. This arm will be restricted to subjects who plan to undergo focal therapy.
Drug: Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC
Subjects have two visits (the second visit being optional) within two years. During each visit, they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical

Experimental: PET/CT
PET/CT with Gallium-68 labeled PSMA-HBED-CC: Subjects will have one visit during which they will undergo a PET/CT after being injected with the study drug, Gallium-68 labeled PSMA-HBED-CC.
Drug: PET/CT with Gallium-68 labeled PSMA-HBED-CC
Subjects have one visit, during which they will undergo one PET/CT with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical




Primary Outcome Measures :
  1. Sensitivity and specificity, of 68Ga-PSMA-HBED-CC PET [ Time Frame: Up to two time points (approx. 2 hours each) within 2 years or less ]
    Compare the diagnostic performance, presented as comparative sensitivity and specificity, of 68Ga-PSMA-HBED-CC PET versus conventional MRI in a population of patients with prostate cancer.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  1. Male aged 21 years or older.
  2. Ability to provide signed informed consent and willingness to comply with protocol requirements.
  3. Pathologic confirmation of adenocarcinoma of the prostate gland or high clinical suspicion (PSA > 4 ng/mL, or PSA density > 0.15 ng/mL2, or PSA doubling time < 2 years).
  4. Meet one of the following 5 criteria

    1. Planned for surgical extirpation, which may or may not include lymph node dissection (high risk primary disease)
    2. Planned for targeted biopsy of primary lesion
    3. Conventional imaging equivocal or suggestive of prostate cancer metastasis/es
    4. Planned focal therapy (with or without radiation therapy) with serial follow-up
    5. Elevated PSA with no conventional imaging suggestive of metastatic or recurrent disease
  5. a. If part of PET/MRI cohort, subject will undergo clinically indicated MRI imaging prior to treatment.

    Or b. If part of PET/CT cohort, subject will have had clinically indicated MRI within 3 months prior to treatment.

  6. Participants must agree to use an acceptable form of birth control throughout the study period. Participants must use condoms for a period of seven days after each injection, if engaged in sexual activity.

Exclusion Criteria:

  1. Clinical and/or technical factors that would compromise statistical analysis of the PET and/or MRI.
  2. If part of PET/MRI cohort and patient cohort 3 or 5, subject does not plan to have a prescribed abdomen and pelvis MRI
  3. If part of PET/MRI cohort and patient cohort 1, 2 or 4, subject does not plan to have a prescribed pelvis MRI
  4. If part of PET/CT cohort and patient cohort 3 or 5, subject does not have previous MR imaging of abdomen and pelvis
  5. If part of PET/CT cohort and patient cohort 1, 2 or 4, subject does not have previous MR imaging of pelvis
  6. If part of PET/CT cohort, investigator review determines that previous MR images do not meet institutional quality standards
  7. If part of PET/MRI cohort, contraindications to MRI
  8. Contraindications to PSMA IV administration
  9. Other unspecified reasons that, in the opinion of investigators, make the subject unsuitable for enrollment

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): NCT03439033


Contacts
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Contact: Meagan Cea, M.A. 212-746-6055 mec2030@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Meagan Cea, M.A.    212-746-6055    mec2030@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: John W. Babich, Ph.D. Weill Medical College of Cornell University
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03439033    
Other Study ID Numbers: 1706018301
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 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
Keywords provided by Weill Medical College of Cornell University:
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Edetic Acid
N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents