NCT05035732

Brief Summary

To perform both PET scans and MRIs in the same setting using a simultaneous PET/MRI scanner.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2021

Status
withdrawn

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

March 25, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

2.8 years

First QC Date

August 24, 2021

Last Update Submit

January 17, 2024

Conditions

Prostate CancerProstate Nodule

Outcome Measures

Primary Outcomes (1)

  • To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI

    through study completion, an average of 1 year

Study Arms (1)

18F-ACBC

EXPERIMENTAL
Radiation: 18F-fluciclovine

Interventions

18F-fluciclovineRADIATION

IV

18F-ACBC

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients who are 18 years and older
  • Histologically or cytologically proven prostate carcinoma s/p definitive radiation
  • Patients suspected to have BCR based on phoenix criteria (prostate specific antigen value (PSA) of 2 ng/mL above the PSA nadir)
  • Ability to understand and willingness to sign informed consent

You may not qualify if:

  • Patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
  • Patients with contraindication to undergo MRI
  • Patients with prior allergy to MRI contrast agent.
  • Extreme Claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Devaki S Surasi

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

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

August 24, 2021

First Posted

September 5, 2021

Study Start

March 25, 2021

Primary Completion

January 17, 2024

Study Completion

January 17, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share