NCT01712815

Brief Summary

This phase I trial studies the side effects of positron emission tomography (PET)/computed tomography (CT) in evaluating response to chemotherapy in patients with breast cancer. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

October 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 22, 2013

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

8.9 years

First QC Date

October 18, 2012

Last Update Submit

August 9, 2023

Conditions

HER2-positive Breast CancerRecurrent Breast CancerStage IA Breast CancerStage IB Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Change of FMAU-PET score vs. change of Ki-67 from the baseline to post-chemotherapy

    Up to 1 year

  • Incidence of adverse events

    Up to 24 hours after completion of study treatment

Study Arms (1)

Diagnostic (fluorine F 18-clevudine PET/CT)

EXPERIMENTAL

Patients receive fluorine F18-clevudine IV over 1 minute and then undergo PET/CT scan at baseline. Patients with HER2+ breast cancer also undergo fluorine F 18-clevudine PET/CT scan 2-3 weeks after the first course of treatment and after completion of treatment.

Other: laboratory biomarker analysisOther: pharmacological studyOther: questionnaire administrationRadiation: fluorine F 18-clevudineProcedure: positron emission tomography/computed tomography

Interventions

laboratory biomarker analysisOTHER

Correlative studies

Diagnostic (fluorine F 18-clevudine PET/CT)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Diagnostic (fluorine F 18-clevudine PET/CT)
questionnaire administrationOTHER

Ancillary studies

Diagnostic (fluorine F 18-clevudine PET/CT)
fluorine F 18-clevudineRADIATION

Undergo fluorine F 18-clevudine PET/CT scan

Also known as: 18F-2'-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil-clevudine, 18F-FMAU
Diagnostic (fluorine F 18-clevudine PET/CT)
positron emission tomography/computed tomographyPROCEDURE

Undergo fluorine F18-clevudine PET/CT scan

Diagnostic (fluorine F 18-clevudine PET/CT)

Eligibility Criteria

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

You may qualify if:

  • Scheduled to receive therapy with trastuzumab plus chemotherapy as part of standard care
  • Have one or more breast tumors visualized by conventional PET/CT, CT or magnetic resonance imaging (MRI) prior to the PET FMAU study; PET/CT should be within a week prior to 18-F FMAU
  • Have been diagnosed with a HER2+ invasive cancer of the breast
  • Scheduled to receive pre-operative therapy with trastuzumab plus chemotherapy as part of standard care
  • Have one or more breast tumors visualized by conventional PET/CT, CT or MRI prior to the PET FMAU study; PET/CT should be within a week prior to 18-F FMAU

You may not qualify if:

  • Have undergone chemotherapy or radiation therapy within the previous one month
  • Women of childbearing potential, unless they have had a negative urine human chorionic gonadotropin (HCG) within the previous 24 hours of the procedure
  • Patients who have had surgery at the site of the suspected lesion within 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Peter Conti, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

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

October 18, 2012

First Posted

October 24, 2012

Study Start

November 22, 2013

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

US(1)