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Completed

NCT Number: NCT00743314

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

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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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

screening questionnaire administration

Other

Computed Tomography

Procedure

Lymphoscintigraphy

Procedure

Single Photon Emission Computed Tomography

Procedure

Intensity-Modulated Radiation Therapy

Radiation

technetium Tc 99m sulfur colloid

Radiation

Primary outcomes

  1. Philips Precedence SPECT/CT® and GE PET/CT Fusion software integration

  2. Dosimetry differences between 3-D conformal radiotherapy with vs without the Philips Precedence SPECT/CT®

  3. Lymph node dosimetry differences between single photon emission computed tomography (SPECT) and computed tomography (CT) with 3-D conformal radiotherapy vs intensity-modulated radiotherapy

  4. Association between radiation exposure and limb volume, circumferential wrist measurements, circumferential forearm measurements, and extra-cellular fluid measurements

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2008
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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