Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA) | NCT04009083

Studies
Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)

NCT04009083

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Mar 30, 2021Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Standard of Care MRI
Fluciclovine PET scan added to MRI

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 19, 2019Actual

Primary Completion Date

Jan 7, 2021Actual

Completion Date

Jan 7, 2021Actual

First Submitted Date

Jul 2, 2019

First Submission Date that Met QC Criteria

Jul 3, 2019

First Posted Date

Jul 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2021

Last Update Posted Date

Mar 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a prospective outcomes study assessing quality of life and oncological control at pre-defined time points following FOCAL CRYO-ABLATION (FCA). The investigator's standard of care is to perform an Magentic Resonance Imaging (MRI) and prostate biopsy two years following FCA. The prostate biopsy assesses both the presence of in field and out of field disease. The role of Axumin PET/MRI for detecting disease following FCA has not been previously examined.

Detailed Description

The primary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of in field recurrence of significant prostate cancer defined as any Gleason pattern 4 disease.

The secondary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of out of field recurrence of significant prostate cancer .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of Care	Other		Device: Standard of Care MRI
18F-Fluciclovine PET Scan	Experimental		Other: Fluciclovine PET scan added to MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard of Care MRI	Device	Prostate MRI, serum Prostate Specific Antigen (PSA), in field and random systemic prostate biopsies	Standard of Care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin)		1 Day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

FCA at NYU Langone Health performed at least two years prior to study enrollment by Drs. Lepor or Wysock.
No prostate cancer specific treatment following FCA
Consented to undergo reflex MRI and prostate biopsy two years following FCA.

Exclusion Criteria:

Any contraindication to prostate biopsy
Prior allergic reaction to 18F-Fluciclovine
Patient refuses MRI and prostate biopsy two years following FCA.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Herbert Lepor, MD	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYU Langone Health		New York	New York	10016	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided