NCT02687139

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 29, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

3.5 years

First QC Date

February 11, 2016

Results QC Date

April 17, 2020

Last Update Submit

April 17, 2020

Conditions

Renal Cell CarcinomaKidney Cancer

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC)

    This was assessed to compare the sites of disease images of patients with RCC on conventional imaging with the images on the 18F-DCFPyL PET/CT to evaluate the sensitivity of DCFPyL PET/CT scans in detecting sites of disease compared to conventional imaging.

    12 Months

  • Number of Participants With a Correlation Between Radiotracer Uptake on 18F-DCFPyL PET/CT and Conventional Imaging

    This was assessed to Correlate Sites of Radiotracer Uptake on 18F-DCFPyL PET/CT With Conventional Imaging Findings.

    12 Months

Study Arms (1)

18F-DCFPyL PET/CT

EXPERIMENTAL
Drug: 18F-DCFPyLProcedure: PET/CT

Interventions

18F-DCFPyLDRUG
18F-DCFPyL PET/CT
PET/CTPROCEDURE

Positron Emission Tomography - Computed Tomography (PET/CT)

18F-DCFPyL PET/CT

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • 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.

    PMID: 31147927DERIVED

MeSH Terms

Conditions

Carcinoma, Renal CellKidney Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Mohamad Allaf, MD
Organization
Johns Hopkins University
mallaf@jhmi.edu
410-502-7710

Study Officials

  • Mohamad Allaf, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2016

First Posted

February 22, 2016

Study Start

October 1, 2015

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

April 29, 2020

Results First Posted

April 29, 2020

Record last verified: 2020-04

Locations

US(1)