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

Breast Cancer Clinical Trial

Official title:

Integration of SPECT/CT Lymphoscintigraphy Into Breast Cancer Radiation for LymphaticSparing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743314
• Other study ID #: CDR0000611987
• Secondary ID: P30CA015083MC073
• Status: Completed
• Phase: Early Phase 1
• Start date: September 2008
• Est. completion date: October 2016

Study information

• Verified date: October 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Intervention

Other:
• screening questionnaire administration

Procedure:
• computed tomography

• lymphoscintigraphy

• single photon emission computed tomography

Radiation:
• intensity-modulated radiation therapy

• technetium Tc 99m sulfur colloid

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Philips Precedence SPECT/CT® and GE PET/CT Fusion software integration
Primary	Dosimetry differences between 3-D conformal radiotherapy with vs without the Philips Precedence SPECT/CT®
Primary	Lymph node dosimetry differences between single photon emission computed tomography (SPECT) and computed tomography (CT) with 3-D conformal radiotherapy vs intensity-modulated radiotherapy
Primary	Association between radiation exposure and limb volume, circumferential wrist measurements, circumferential forearm measurements, and extra-cellular fluid measurements