Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT00581256
Eligibility Criteria:
Inclusion Criteria:
Eligibility Criteria
* Breast cancer diagnosis: Patients must have histologically confirmed adenocarcinoma of the breast requiring comprehensive loco-regional irradiation that includes treatment to the intact breast/chest wall, supraclavicular (SCV), infraclavicular nodes (ICV), and internal mammary nodes (IMN).
* Patients must have pathologic T 1, 2, 3 or 4, N 1, 2, or 3 Stage II or III disease as defined by the AJCC Staging System, 6th edition. Patients who do not undergo axillary staging but are at risk for nodal involvement may also be treated.
* All patients must have left-sided breast cancer.
* Both men and women are eligible.
* Patients must be adults (18 years of age or older)
* For women of child-bearing age, effective contraception must be used. A written statement must be obtained that the patient is not pregnant. If there is any question of pregnancy at time of therapeutic RT or at time of each SPECT-CT scan, a pregnancy test will be done to confirm the patient is not pregnant.
* Performance status should be 0-2 by ECOG criteria.
* Patients that have received prior RT may be enrolled on the present study if the new breast lesion can be treated with no overlap of RT fields.
* Patients must be aware of the neoplastic nature of her/his disease.
* Patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with the Institutional Review Board (IRB) of the University of Michigan and federal guidelines.
* Patients' blood tests should indicate they are able to tolerate radiotherapy. Tests must be done within 28 days of registration:
CBC with differential and platelet count (Hemoglobin \> 8.0 g/dl; wbc \> 2000/mm3; absolute neutrophil count \> 1000/mm3; platelet count \> 75,000/mm3.
Exclusion Criteria:
* Patients who are pregnant or are nursing are excluded.
* Pathologically node negative breast cancer unless treated with neo-adjuvant chemotherapy.
* Performance status \> 2 by ECOG criteria
* Patients who are unable to lie on their back and raise their arm above their head in the treatment planning position for radiotherapy
* Patients with a clinically unstable medical condition
* Patients with a life-threatening disease state
* History or suspicion of serious life-threatening allergic reaction to Tc-99m imaging agents.
* Patients that have had breast-conservation surgery with positive margins or any patient with negative margins with a tumor positive for an extensive intraductal component.
* Patients that are not able to use the ABC device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00581256
Study Brief:
Protocol Section:
NCT00581256