NCT00602628

Brief Summary

RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging and CT scans, may help reduce normal tissue damage in patients undergoing radiation therapy for cancer. PURPOSE: This clinical trial is studying how well radiation therapy planning techniques work in reducing damage to normal tissue in women undergoing breast-conserving surgery for ductal breast carcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2007

Shorter than P25 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

November 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 26, 2013

Status Verified

January 1, 2009

Enrollment Period

8 months

First QC Date

January 24, 2008

Last Update Submit

June 25, 2013

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situinvasive ductal breast carcinomabreast cancer in situstage I breast cancerstage II breast cancerstage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

  • Difference in lung NTDmean (biologically weighted [normalized] mean of total dose to lung normalized to 2 Gy fractions) in supine vs prone positions

Secondary Outcomes (7)

  • Closeness of agreement between MRI-based vs CT scan/clip- based delineation of tumor bed

  • Closeness of agreement between clinical target volumes (CTVs) defined using uniform margin vs those defined using knowledge of all excision margins

  • Difference in NTDmean to ipsilateral non-planning target volume (PTV) breast tissue, chest wall muscle, and heart

  • Difference in mean volume of PTV in supine versus prone positions

  • Difference in dose homogeneity within PTV in each position

  • +2 more secondary outcomes

Interventions

questionnaire administrationOTHER
adjuvant therapyPROCEDURE
biopsyPROCEDURE
computed tomographyPROCEDURE
dynamic contrast-enhanced magnetic resonance imagingPROCEDURE
magnetic resonance imagingPROCEDURE
therapeutic conventional surgeryPROCEDURE
ultrasound imagingPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

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

You may qualify if:

  • Female
  • Menopausal status not specified

You may not qualify if:

  • Cup size DD or greater
  • Ferromagnetic implants (exclude participation in MRI)
  • Claustrophobia (exclude participation in MRI)
  • Gadolinium allergy
  • PRIOR CONCURRENT THERAPY:
  • No prior surgery to ipsilateral breast
  • No prior neoadjuvant chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, NoninfiltratingCarcinoma, Ductal, BreastBreast Carcinoma In Situ

Interventions

Chemotherapy, AdjuvantBiopsyMagnetic Resonance SpectroscopyHigh-Energy Shock WavesRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryCarcinoma, Ductal

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesSpectrum AnalysisChemistry Techniques, AnalyticalUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • John R. Yarnold, MD, FRCR

    Royal Marsden NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2008

First Posted

January 28, 2008

Study Start

November 1, 2007

Primary Completion

July 1, 2008

Study Completion

January 1, 2009

Last Updated

June 26, 2013

Record last verified: 2009-01

Locations

GB(1)