Breast Cancer Clinical Trial

Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer

Summary

RATIONALE: Diagnostic procedures, such as single-photon emission computed tomography and computed tomography lymphoscintigraphy, may help lower the dose of radiation therapy after surgery, and help prevent lymphedema.

PURPOSE: This clinical trial is studying single-photon emission computed tomography and computed tomography lymphoscintigraphy followed by intensity-modulated radiation therapy to see how well they work in treating patients who have undergone surgery for stage I or stage II breast cancer.

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Full Description

OBJECTIVES:

To assess the feasibility of integrating Philips Precedence SPECT/CT® images with GE PET/CT Fusion software to reduce radiation dosimetry delivered to lymph nodes draining the arm in patients after surgery for stage I or II breast cancer.
To examine the differences in radiation dosimetry in these patients using 3-D conformal radiotherapy with vs without the Philips Precedence SPECT/CT®.
To compare reduction in lymph node radiation dosimetry in these patients using single photon emission computed tomography (SPECT) and computed tomography (CT) with 3-D conformal radiotherapy vs intensity-modulated radiotherapy.

OUTLINE: Patients receive filtered technetium Tc 99m sulfur colloid (TcSC) intradermally and undergo single photon emission computed tomography (SPECT) and computed tomography (CT) imaging at the time of TcSC and 2 hours after injection. Patients then undergo intensity-modulated radiotherapy of the whole breast, including the low axilla and lymph nodes identified by the Phillips Precedence SPECT/CT® at a dose determined by computer analysis of the imaging information.

Patients complete a lymphedema screening questionnaire at baseline and at 12 and 24 months after treatment.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Biopsy-proven primary invasive breast cancer, meeting one of the following criteria:

Stage I or II disease with negative sentinel or axillary node dissections
Stage II disease with micrometastases (defined as < 2.0 mm focus) in 1-2 lymph nodes and/or a single positive axillary node ≤ 1 cm with no extracapsular extension
Completed all surgical intervention (e.g., lumpectomy, mastectomy)
Planning adjuvant whole breast irradiation including the low axilla
No bilateral or recurrent breast cancer

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Not pregnancy or nursing
Negative pregnancy test
Able to complete questionnaire(s) alone or with assistance
No active infection
No history of invasive cancer within the past 5 years, except basal cell or squamous cell skin cancers

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior surgery or radiation to the ipsilateral breast or axilla
No concurrent neoadjuvant chemotherapy or radiotherapy

Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

30

Study ID:

NCT00743314

Recruitment Status:

Completed

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic
Rochester Minnesota, 55905, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

30

Study ID:

NCT00743314

Recruitment Status:

Completed

Sponsor:


Mayo Clinic

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