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 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT02688166
Eligibility Criteria:
Inclusion Criteria:
* Breast cancer patients who are undergoing internal mammary lymph node radiation which is the investigators institutional policy for patients with axillary lymph node involvement
* Clinical AJCC (AJCC, 7th ed.) II, IIIA or IIIB with non-operable disease or those who refuse surgery who are recommended concurrent chemoradiation. Patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor are eligible.
* Any lung cancer, thymic cancer or mesothelioma patient getting either chemoradiation or radiation alone wherein heart gets radiation exposure
* Patients who have received systemic treatment (up to 4 cycles of induction chemotherapy, or up to 6 months of targeted therapy) and are rendered candidate for concurrent chemoradiation are also eligible
* Patients with recurrent disease overlapping or in close proximity to heart getting hypofractionated or conventionally fractionated proton therapy alone.
* Intensity modulated radiotherapy, 3-D conformal radiotherapy, electron radiotherapy, and proton radiotherapy will be permitted.
* Patients who develop local or nodal recurrence after surgery and rendered candidate for definitive concurrent chemoradiation are also eligible.
* The patient must give protocol-specific consent on an IRB approved consent form prior to completion of protocol specific testing/procedures.
* 18 years of age or older.
Exclusion Criteria:
* Pregnant/breast feeding patients or those not willing to undertake contraception if of child-producing potential while on study
* Patients with Stage IV disease
* Patients with contraindications to MRI examination (e.g. gadolinium allergies/reactions, metallic implants, incompatible implanted electronic/cardiac devices, over scanner weight tolerance etc.)
* Patients with hepatorenal syndrome
* Patients with Chronic Kidney Disease defined as eGFR \<30 ml/min
* Patients unable to lie supine for 30 minutes for MRI examination
* Patients having undergone prior radiation therapy to the chest
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02688166
Study Brief:
Protocol Section:
NCT02688166