NCT00804128

Brief Summary

\*REFERRALS TO THIS TRIAL MUST BE THROUGH BREAST CARE CLINICIANS ONLY\* RATIONALE: Diagnostic procedures, such as contrast-enhanced MRI, may help find and diagnose ductal carcinoma in situ. PURPOSE: This study is to develop and refine magnetic resonance (MR) imaging methods for pre-operative staging of ductal carcinoma in situ, a pre-invasive form of breast cancer, and atypical ductal hyperplasia, a risk factor for developing cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

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

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
15.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2024

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

15.3 years

First QC Date

December 5, 2008

Last Update Submit

January 17, 2024

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situ

Outcome Measures

Primary Outcomes (2)

  • Comparison of ductal carcinoma in situ (DCIS)-optimized MRI quality

    Conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality will be used to determine the overall image quality for each MRI.

    1 month

  • Comparison of two DCIS-optimized MRIs for variability in enhancement levels for DCIS

    Conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality will be used to determine the overall image variability for each MRI.

    1 month

Study Arms (1)

Breast Cancer patients

Adult, breast cancer patients with confirmed Ductal Carcinoma in Situ (DCIS) or atypical ductal hyperplasia (ADH)

Procedure: Magnetic Resonance Imaging (MRI)Drug: Gadavist

Interventions

Magnetic Resonance Imaging (MRI)PROCEDURE

Undergo MRI

Also known as: MRI
Breast Cancer patients
GadavistDRUG

Gadavist injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging

Also known as: Gadobutrol
Breast Cancer patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants receiving care for breast cancer who also have a biopsy proven DCIS or ADH.

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Patients at the University of California, San Francisco Breast Care Center meeting the following criteria: * Biopsy proven ductal carcinoma in situ (DCIS) of the breast. * Has undergone mammography within the past 60 days. * ADH patients: over 18, no prior history of breast disease. PATIENT CHARACTERISTICS: * Referrals to this trial are through breast care clinicians only * Not pregnant or nursing (or stopped nursing within the past 3 months) * Negative pregnancy test * No contraindication to MRI (e.g., implanted pacemaker, implanted ferromagnetic device, ferromagnetic aneurysm clip, severe claustrophobia, ocular metal fragments, or shrapnel injury) PRIOR CONCURRENT THERAPY: * More than 2 years since prior surgery to the ipsilateral breast (patient) * No prior radiotherapy to the ipsilateral breast (patient) * No prior cytotoxic regimens (patient)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Interventions

Magnetic Resonance Spectroscopygadobutrol

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Nola M. Hylton, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Bonnie Joe, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 8, 2008

Study Start

October 1, 2008

Primary Completion

January 5, 2024

Study Completion

January 5, 2024

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)