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WILL MULTIFUNCTIONAL MAGNETIC RESONANCE TECHNIQUES, DETAILED HISTOPATHOLOGICAL ANALYSIS AND PRONE TREATMENT POSITION IMPROVE ACCURACY OF TARGET VOLUME LOCALISATION & DEFINITION AND REDUCE EXPOSURE OF NORMAL TISSUES IN BREAST RADIOTHERAPY?


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

WILL MULTIFUNCTIONAL MAGNETIC RESONANCE TECHNIQUES, DETAILED HISTOPATHOLOGICAL ANALYSIS AND PRONE TREATMENT POSITION IMPROVE ACCURACY OF TARGET VOLUME LOCALISATION & DEFINITION AND REDUCE EXPOSURE OF NORMAL TISSUES IN BREAST RADIOTHERAPY?


OBJECTIVES:

- To improve precision of tumor bed localization and definition of clinical target
volume, and to reduce normal tissue irradiation in women undergoing partial breast or
breast boost radiotherapy.

- To test whether post-operative MRI improves the precision of tumor bed delineation
after wide-local excision in comparison with the current standard CT scan/clip method.

- To determine the impact of tumor position within the excision specimen upon the
localization of clinical target volume in relation to the tumor bed.

- To compare theoretical non-target tissue exposure from partial breast irradiation
planned in the supine and prone (face-down) positions.

OUTLINE: Patients undergo planned breast-conservation surgery and placement of titanium
clips to the four radial, the deep, and superficial margins of the excision cavity (for
localization of tumor bed).

Within 2 weeks after surgery, patients undergo supine radiotherapy-planning CT scan as
standard analysis. Patients then undergo a radiotherapy-planning CT scan in the prone
position. Patients complete a linear analogue questionnaire after both scans designed to
assess patient comfort and anxiety in each position. Patients then undergo multifunctional
MRI (including dynamic contrast-enhancement MRI and diffusion-weighted MRI) of the
ipsilateral breast in the prone position (≥ 3 weeks after surgery). If suspicious lesions ≥
5 mm are found on MRI, patients are referred for a second-look ultrasound with biopsy (if
lesion visible on ultrasound); where suspicious lesions are seen only on MRI, patients
undergo MRI-guided biopsy. Lesions < 5 mm are included in the whole-breast radiotherapy
treatment.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Planning to undergo breast-conserving surgery (BCS)* for unifocal ductal carcinoma in
situ (DCIS) or grade 1-2 invasive ductal carcinoma (IDC) of the breast NOTE:
*Patients who have underwent BCS and have titanium clips placed according to this
protocol are eligible for this study.

- No T4d or multifocal disease (as defined on mammography or ultrasound)

- No G3 disease

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Female

- Menopausal status not specified

Exclusion criteria:

- 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

John R. Yarnold, MD, FRCR

Investigator Role:

Study Chair

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

United States: Federal Government

Study ID:

RMH-CCR2981

NCT ID:

NCT00602628

Start Date:

November 2007

Completion Date:

January 2009

Related Keywords:

  • Breast Cancer
  • ductal breast carcinoma in situ
  • invasive ductal breast carcinoma
  • breast cancer in situ
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms
  • Carcinoma, Ductal, Breast

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