R37CA249659

Advanced Diffusion MRI for Evaluating Early Response to Radiation Treatment in Cervical Cancer - Project Summary

Despite the advent of aggressive cervical cancer screening programs, cervical cancer remains one of the most common cancers affecting women under the age of 35, and the fourth most common cause of cancer death worldwide. The standard of care for early stage (IB) cervical cancer is hysterectomy or radiation. Unfortunately, the consequences of radical treatment include fertility loss, nerve injury causing bladder and bowel dysfunction, and pelvic pain. There is a critical need to reduce cervical cancer mortality while minimizing the potential morbidities of treatment.

To achieve this end, refined approaches for diagnosis and evaluation of response to treatment using noninvasive biomarkers are needed to differentiate indolent from clinically significant disease at the earliest possible time point. Currently, PET/CT is the mainstay in evaluating response to treatment, but it is highly confounded by post-treatment changes such as edema. Magnetic Resonance Imaging (MRI) with advanced diffusion-weighted imaging may offer an alternative approach to evaluate treatment response, with additional advantages of being a radiation-free and contrast media-free exam.

The overall objective of this application is to develop and evaluate a robust advanced diffusion-weighted imaging technique that provides a highly sensitive and specific reflection of cervical cancer tumor burden and treatment response at the earliest possible time point. Our hypothesis is that Restriction Spectrum Imaging (RSI), an advanced diffusion imaging technique, is as sensitive and specific as the standard of care post-treatment PET/CT for evaluation of treatment efficacy of cervical cancer and can be performed three months earlier than standard of care PET/CT.

The aims of this proposal are:
1) Determine the RSI model for cervical cancer evaluation.
2) Develop and validate a cervical cancer classification algorithm from multi-parametric MRI based on the aim 1 biophysical model using established machine learning techniques.
3) Prospectively validate RSI-MRI compared to PET/CT in evaluating response to radiation treatment in cervical cancer patients (stage IB) in a pilot study.

The main significance of this study is the development of a radiation-free and non-contrast imaging technique for evaluating response to treatment three months earlier than the current standard of care PET/CT. This will allow appropriate treatment earlier, preventing unnecessary progression of the disease. The innovation proposed involves developing a diffusion model specific for cervix imaging within the RSI framework based on the biophysical characteristics of healthy and malignant cervical tissue. We will then apply this quantitative technique prospectively on a preliminary cohort of patients before and after treatment and compare it to the standard of care PET/CT imaging.

At the completion of the study, a new tool for evaluating response to treatment in cervical cancer that is contrast and radiation-free will be available. This is directly translatable to the clinical setting to benefit cervical cancer patients. Cervical cancer patients will be better served, particularly those not responding to treatment, as they can be directed to appropriate treatment at an earlier time point.

San Diego University Of California

TO IMPROVE SCREENING AND EARLY DETECTION STRATEGIES AND TO DEVELOP ACCURATE DIAGNOSTIC TECHNIQUES AND METHODS FOR PREDICTING THE COURSE OF DISEASE IN CANCER PATIENTS. SCREENING AND EARLY DETECTION RESEARCH INCLUDES DEVELOPMENT OF STRATEGIES TO DECREASE CANCER MORTALITY BY FINDING TUMORS EARLY WHEN THEY ARE MORE AMENABLE TO TREATMENT. DIAGNOSIS RESEARCH FOCUSES ON METHODS TO DETERMINE THE PRESENCE OF A SPECIFIC TYPE OF CANCER, TO PREDICT ITS COURSE AND RESPONSE TO THERAPY, BOTH A PARTICULAR THERAPY OR A CLASS OF AGENTS, AND TO MONITOR THE EFFECT OF THE THERAPY AND THE APPEARANCE OF DISEASE RECURRENCE. THESE METHODS INCLUDE DIAGNOSTIC IMAGING AND DIRECT ANALYSES OF SPECIMENS FROM TUMOR OR OTHER TISSUES. SUPPORT IS ALSO PROVIDED FOR ESTABLISHING AND MAINTAINING RESOURCES OF HUMAN TISSUE TO FACILITATE RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.394 - Cancer Detection and Diagnosis Research

National Cancer Institute (NCI) [HHS - NIH]

La Jolla, California 92093 United States

Single Zip Code

Research Project Grant (Parent R01 Clinical Trial Not Allowed) (PA-19-056)

Amendment Since initial award the total obligations have increased 392% from $640,083 to $3,147,525.