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Study of PSMA-targeted 18F-DCFPyL PET/CT in the Evaluation of Patients With Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02687139
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
In this study the investigators aim to evaluate diagnostic utility of PSMA-targeted 18F-DCFPyL PET/CT in patients with renal cell carcinoma.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Kidney Cancer Drug: 18F-DCFPyL Procedure: PET/CT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of PSMA-targeted 18F-DCFPyL PET/CT in the Evaluation of Patients With Renal Cell Carcinoma
Study Start Date : October 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-DCFPyL PET/CT Drug: 18F-DCFPyL
Procedure: PET/CT
Positron Emission Tomography - Computed Tomography (PET/CT)




Primary Outcome Measures :
  1. Sensitivity of 18F-DCFPyL PET/CT for the detection of sites of metastatic renal cell carcinoma found on conventional imaging [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically diagnosed or histologically proven stage II-IV renal cell carcinoma
  • Completed staging evaluation with computed tomography (CT) or magnetic resonance imaging (MRI) of the chest, abdomen and pelvis ≤90 days prior to study enrollment

Exclusion Criteria:

  • History of other malignancy diagnosed within the last 3 years (with the exception of low risk prostate cancer, ductal carcinoma in situ of the breast, squamous cell carcinoma or basal cell carcinoma of the skin)
  • Administered a radioisotope within 5 physical half-lives prior to study enrollment
  • Pregnancy ((as determined in accordance with the policies of the positron emission tomography (PET) center))
  • Intention to enroll in a blinded therapeutic clinical trial following Positron emission tomography-computed tomography (PET/CT)

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): NCT02687139


Contacts
Contact: Michael A. Gorin, M.D. (410) 614-8151 mgorin1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Michael A. Gorin, M.D.    410-614-8151    mgorin1@jhmi.edu   
Principal Investigator: Mohamad E. Allaf, M.D.         
Sub-Investigator: Michael A. Gorin, M.D.         
Sub-Investigator: Steven P. Rowe, M.D., Ph.D.         
Sub-Investigator: Martin G. Pomper, M.D., Ph.D.         
Sponsors and Collaborators
Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02687139     History of Changes
Other Study ID Numbers: IRB00075596
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases