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Feasibility Study of Motility Contrast Tomography for Predicting Therapeutic Response
Sponsor study identifier
observational
150
1 country
1
Study Start
June 22, 2017
Actual (reported)Primary Completion
June 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 22, 2017
Actual (reported)November 8, 2018
Actual (reported)November 13, 2018
Actual (reported)June 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Objective pathological response measured at the time of cystectomy.
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.
Cystectomy is generally expected to occur 12-16 weeks after biopsy is obtained from a TURBT procedure.
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.
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Patients of all races and ethnic groups are eligible for this study. Patients will be recruited from participating sites after interpretation of imaging or other factors indicative of bladder cancer, but prior to performance of a TURBT procedure per routine care guidelines.
Animated Dynamics, Inc.
Indianapolis, Indiana, 46241, United States
Laviana AA, Schiftan EG, Mashni JW, Large MC, Kaimakliotis HZ, Nolte DD, Turek JJ, An R, Morgan TA, Chang SS. Biodynamic prediction of neoadjuvant chemotherapy response: Results from a prospective multicenter study of predictive accuracy among muscle-invasive bladder cancer patients. Urol Oncol. 2023 Jun;41(6):295.e9-295.e17. doi: 10.1016/j.urolonc.2022.11.017. Epub 2022 Dec 13.
Travis A Morgan, MBA
Animated Dynamics, Inc.
First Submitted
November 8, 2018
First Posted
November 13, 2018
Study Start
June 22, 2017
Actual (reported)Primary Completion
June 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
June 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 13, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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