Onco4D(TM) Biodynamic Chemotherapy Selection for Bladder Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03739177|
Recruitment Status : Recruiting
First Posted : November 13, 2018
Last Update Posted : January 13, 2020
Millions of cancer patients every year receive chemotherapy with only a 20-60% probability of pathological response, while most experience adverse side effects that lower quality of life without prolonging it. Reliable identification of ineffective therapies can eliminate needless human suffering while increasing overall probability of positive response to treatment. Chemotherapy resistance profiling entails testing whether a patient exhibits strong resistance to a therapy prior to its final selection by the oncologist. However, there are no effective methods for quickly assessing patient chemotherapy resistance. Patient Derived Xenograft (PDX) models have replaced older Chemotherapy Sensitivity and Resistance Assays (CSRAs) to some degree, but both technologies suffer from long testing times, high cost, and/or low accuracy.
Motility Contrast Tomography (MCT) has recently emerged as a technology that measures the biodynamic response of intact tumor biopsies to applied therapeutics by using Doppler detection of infrared light scattered from intracellular motions inside living tissue. Several small scale animal, xenograft, and human studies have shown this phenotypic profiling technique to be highly accurate in prediction of response and resistance to chemotherapy. This project will be the first human trial of biodynamic phenotyping to predict chemotherapy response among bladder cancer patients. Specifically, the study cohort will include patients selected for neoadjuvant chemotherapy treatment, because this setting offers the opportunity for near-term outcome measurement at the time of post-chemo surgery. Pre-therapy fresh tumor specimens will be imaged using MCT, and the resulting bio-dynamic signatures will be compared to confirmed pathological response at the time of surgery. Observation of a high predictive value will provide the basis for expanded clinical trials and prompt commercialization of a biodynamic chemotherapy selection assay for bladder and other cancer patients.
|Condition or disease||Intervention/treatment|
|Bladder Cancer||Diagnostic Test: Onco4D Biodynamic Chemotherapy Selection Assay|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Feasibility Study of Motility Contrast Tomography for Predicting Therapeutic Response|
|Actual Study Start Date :||June 22, 2017|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
- Diagnostic Test: Onco4D Biodynamic Chemotherapy Selection Assay
The Onco4D Biodynamic Chemotherapy Selection Assay uses Motility Contrast Tomography (MCT) to measure ex-vivo fresh tumor biopsy response when challenged by an array of chemotherapeutic agents. A machine learning algorithm uses the MCT datastream to predict in vivo tumor response or non response to chemotherapy.
- Objective pathological response measured at the time of cystectomy. [ Time Frame: Cystectomy is generally expected to occur 12-16 weeks after biopsy is obtained from a TURBT procedure. ]The study will be considered successful, if a majority of specimens yield interpretable MCT results, and if MCT signatures are identified which demonstrate a high statistical correlation to confirmed patient response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739177
|Contact: Travis A Morgan, MBA||800-963-3313 ext email@example.com|
|United States, Indiana|
|Animated Dynamics, Inc.||Recruiting|
|Indianapolis, Indiana, United States, 46241|
|Contact: Travis A Morgan 800-963-3313 ext 702 firstname.lastname@example.org|
|Principal Investigator: Ran An, Ph.D.|
|Study Director:||Travis A Morgan, MBA||Animated Dynamics, Inc.|