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
United States30 participantsStarted 2008-09
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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