NCT01672021

Brief Summary

Because MRI can provide increased brain and liver lesion detection as compared with CT, the investigators hypothesize that FDG-PET/MRI will provide concordant or improved lesion detection as compared with FDG-PET/CT in breast cancer patients at a decreased radiation dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable breast-cancer

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

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2012

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2021

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

9.3 years

First QC Date

August 21, 2012

Last Update Submit

October 12, 2021

Conditions

Breast Cancer

Keywords

Breast CancerMRI PET-CT

Outcome Measures

Primary Outcomes (1)

  • Number of metastatic lesions seen on PET/MRI as compared with PET/CT

    1 year

Secondary Outcomes (1)

  • Patient stage as imaged by PET/MRI as compared with PET/CT

    1 year

Study Arms (1)

PET/MRI

OTHER

PET/MRI

Procedure: PET/MRI

Interventions

PET/MRIPROCEDURE

PET/MRI

PET/MRI

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient with a history or breast cancer undergoing PET/CT either for initial staging or for disease surveillance

You may not qualify if:

  • Pregnant patients and patients with known contraindications for whole body MR imaging (e.g., pacemakers, recent surgery, brain vascular clips, etc.) will be excluded from the study. Patients will be screened with a questionnaire to be sure they have no medical devices that could make the procedure unsafe. Patients with glomerular filtration rate (GFR) \< 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Laura Heacock, MD

    NYU School of Medicine

    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

August 21, 2012

First Posted

August 24, 2012

Study Start

July 1, 2012

Primary Completion

October 5, 2021

Study Completion

October 5, 2021

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

US(1)