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 - Full Text View

Sponsors and Collaborators:	Mayo Clinic National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00743314

Purpose

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.

Condition	Intervention
Breast Cancer Cancer-Related Problem/Condition	Procedure: computed tomography Procedure: intensity-modulated radiation therapy Procedure: lymphoscintigraphy Procedure: screening questionnaire administration Procedure: single photon emission computed tomography Procedure: technetium Tc 99m sulfur colloid

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome

MedlinePlus related topics: Breast Cancer CT Scans Cancer Lymphedema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	Integration of SPECT/CT Lymphoscintigraphy Into Breast Cancer Radiation for LymphaticSparing

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Philips Precedence SPECT/CT® and GE PET/CT Fusion software integration [ Designated as safety issue: No ]
Dosimetry differences between 3-D conformal radiotherapy with vs without the Philips Precedence SPECT/CT® [ Designated as safety issue: No ]
Lymph node dosimetry differences between single photon emission computed tomography (SPECT) and computed tomography (CT) with 3-D conformal radiotherapy vs intensity-modulated radiotherapy [ Designated as safety issue: No ]
Association between radiation exposure and limb volume, circumferential wrist measurements, circumferential forearm measurements, and extra-cellular fluid measurements [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Detailed 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 30 minutes 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Recovered from prior primary surgery
No prior surgery or radiation to the ipsilateral breast or axilla
No concurrent neoadjuvant chemotherapy or radiotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743314

Locations

United States, Minnesota
Mayo Clinic Cancer Center	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Andrea L. Cheville, MD, MSCE

Mayo Clinic

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Mayo Clinic Cancer Center ( Clinical Trials Office )
Study ID Numbers:	CDR0000611987, MAYO-MC0734, MAYO-07-008292
Study First Received:	August 27, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00743314
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

lymphedema
stage I breast cancer
stage II breast cancer

Study placed in the following topic categories:

Lymphedema
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009