FACBC Prostate Therapy Response

NCT02830880 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-01-07

Study results available
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Summary

The purpose of this study is to assess if using anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) PET scan will be useful in determining if participants are responding to chemotherapy treatment. Investigators will enroll participants whose cancer has been treated with hormone therapy and now the cancer is not responding to the treatment (castration -resistant), and so therefore will be started on chemotherapy. Investigators aim to enroll thirty participants in this study.

Conditions

Interventions

DRUG

FACBC PET-CT

Anti-3-\[18F\]FACBC is an investigational positron emission tomography (PET) radiotracer being studied given intravenously prior to PET scan.

OTHER

MRI, CT, or Bone Scan

Conventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings.

Sponsors & Collaborators

  • Blue Earth Diagnostics

    collaborator INDUSTRY
  • Nihon Medi-Physics Co., Ltd.

    collaborator INDUSTRY
  • Emory University

    lead OTHER

Principal Investigators

  • David Schuster, MD · Emory University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-12-01
Completion
2019-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02830880 on ClinicalTrials.gov