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Onco4D(TM) Biodynamic Chemotherapy Selection for Bladder Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03739177
Recruitment Status : Recruiting
First Posted : November 13, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Animated Dynamics, Inc.

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

INCLUSION CRITERIA: To be eligible for the study, participants must meet the following criteria:

  1. Ability to understand and willingness to sign an informed consent and authorization for release of tissue not required for pathologic diagnosis to be used for research purposes
  2. ≥ 18 years old at time of consent
  3. Patients undergoing a TURBT procedure due to diagnose muscle invasive bladder cancer

EXCLUSION CRITERIA: To be eligible for the study, participants must not be or have any of the following:

  1. Women who are pregnant or breastfeeding
  2. Known tumor genetics or other factors, which in the treating physician's professional judgement, make the patient an unlikely candidate to receive chemotherapy (either neoadjuvantly or adjuvantly)

Information from the National Library of Medicine

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


Contacts
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Contact: Travis A Morgan, MBA 800-963-3313 ext 702 tmorgan@anidyn.com

Locations
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United States, Indiana
Animated Dynamics, Inc. Recruiting
Indianapolis, Indiana, United States, 46241
Contact: Travis A Morgan    800-963-3313 ext 702    tmorgan@anidyn.com   
Principal Investigator: Ran An, Ph.D.         
Sponsors and Collaborators
Animated Dynamics, Inc.
Investigators
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Study Director: Travis A Morgan, MBA Animated Dynamics, Inc.
  Study Documents (Full-Text)

Documents provided by Animated Dynamics, Inc.:
Study Protocol  [PDF] March 1, 2017

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Responsible Party: Animated Dynamics, Inc.
ClinicalTrials.gov Identifier: NCT03739177    
Other Study ID Numbers: 002
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Animated Dynamics, Inc.:
Neoadjuvant Chemotherapy, Muscle Invasive Bladder Cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases