Stereotactic Magnetic Resonance Guided Radiation Therapy

  • STATUS
    Recruiting
  • End date
    Jun 17, 2024
  • participants needed
    1000
  • sponsor
    Dana-Farber Cancer Institute
Updated on 17 June 2021
cancer
stereotactic body radiation therapy
primary cancer

Summary

This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer.

  • The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer.
  • Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measures

Description

This research study is a feasibility study, which means it is the first-time investigators at this institution are examining this type of MR-guided radiation to treat cancer.

The U.S. Food and Drug Administration (FDA) has approved this device as a treatment option for cancer.

In this research study, the investigators are hoping to determine if adjusting radiation treatments based on daily MRI has a feasible way to deliver radiation for participants with pancreatic, lung or renal cancer.

Details
Condition Malignant neoplasm of prostate, Pancreatic Cancer, Pulmonary Disease, urinary tract neoplasm, Malignant neoplasm of kidney, Nephropathy, Cancer, Prostatic disorder, Second Malignancy, Lung Neoplasm, Bronchial Neoplasm, synchronous neoplasms, Prostate Disorders, Liver Metastases, Kidney Disease (Pediatric), Cancer/Tumors, Prostate Cancer, Early, Recurrent, Ewing's Family Tumors, Liver Metastasis, Secondary Malignant Neoplasm of Liver, Hepatic Metastases, Cancer (Pediatric), Islet Ce417ll Cancer, Kidney Cancer, Lung Cancer, Prostate Cancer, Kidney Disease, Lung Disease, Neoplasms, Renal Cancer, Urologic Cancer, prostate carcinoma, adrenal metastases, second malignancies, cancer of the pancreas, cancer, renal, prostate cancers, pancreatic cancers, cancer, pancreatic, carcinoma lung, lung carcinoma, Oligoprogressive, Oligoprogressive Nodal Metastases, Metachronous Nodal Metastases, Synchronous Nodal Metastases
Treatment MR-guided Linac
Clinical Study IdentifierNCT04115254
SponsorDana-Farber Cancer Institute
Last Modified on17 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must have a confirmed malignancy requiring stereotactic body radiation therapy. See specific disease site cohorts for more details
Tumor size 7cm
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
Specific eligibility requirements for each disease site with be covered in each specific cohort

Exclusion Criteria

Specific exclusion requirements for each disease site with be covered in each specific cohort
History of allergic reactions attributed to gadolinium-based IV contrast
\-- Note: If a patient will not receive contrast, this is not applicable
Pregnant women are excluded from this study
Severe claustrophobia or anxiety
Participants who cannot undergo an MRI
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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