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

NCT ID: NCT02687139

Last Updated: 2020-04-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-04-30

Brief Summary

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In this study the investigators aim to evaluate diagnostic utility of prostate-specific membrane antigen (PSMA)-targeted 18F-DCFPyL PET/CT in patients with renal cell carcinoma (RCC).

Detailed Description

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Conditions

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Renal Cell Carcinoma Kidney Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-DCFPyL PET/CT

Group Type EXPERIMENTAL

18F-DCFPyL

Intervention Type DRUG

PET/CT

Intervention Type PROCEDURE

Positron Emission Tomography - Computed Tomography (PET/CT)

Interventions

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18F-DCFPyL

Intervention Type DRUG

PET/CT

Positron Emission Tomography - Computed Tomography (PET/CT)

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamad Allaf, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Meyer AR, Carducci MA, Denmeade SR, Markowski MC, Pomper MG, Pierorazio PM, Allaf ME, Rowe SP, Gorin MA. Improved identification of patients with oligometastatic clear cell renal cell carcinoma with PSMA-targeted 18F-DCFPyL PET/CT. Ann Nucl Med. 2019 Aug;33(8):617-623. doi: 10.1007/s12149-019-01371-8. Epub 2019 May 30.

Reference Type DERIVED
PMID: 31147927 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB00075596

Identifier Type: -

Identifier Source: org_study_id

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