Clinical Onboard Utilization of Image Guided Radiation Therapy with Magnetic Resonance (CONFIRM): A Master Protocol

ENROLLING
Protocol # :
19-665
Conditions
Gastric Cancer
Invasive Breast Cancer
in Situ Breast Cancer
Mantle Cell Lymphoma
Larynx Cancer
Bladder Cancer
Phase
I/II
Disease Sites
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Hodgkin's Lymphoma
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Mak, Raymond
Site Research Nurses
Mann, Eileen, Marie
Spicer, Beverly, A.

Trial Description

This research is being done to determine the safety and feasibility of using a type of
radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with
gastric and breast cancer. The name of the radiation machine involved in this study is the
MRIdian Linear Accelerator.

Eligibility Requirements

Inclusion Criteria:

- Participants must have histologically or cytologically confirmed malignancy requiring
radiation

- Age 18 years of older

- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)

- Ability to understand and the willingness to sign a written informed consent document.

- Any further criteria listed in the specific disease site cohort

Exclusion Criteria

- History of allergic reactions attributed to gadolinium-based IV contrast

-- Note: If patient will not receive contrast, this is not applicable and kidney
function will not affect eligibility

- Severe claustrophobia or anxiety

- Participants who cannot undergo an MRI

- Any other exclusion criteria listed in the specific disease site cohort

19-665