Onco4D(TM) Biodynamic Chemotherapy Selection for Bladder Cancer Patients

NCT03739177 | Unknown

• 1 other identifier: 002
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Neoadjuvant Chemotherapy, Muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Onco4D Biodynamic Chemotherapy Selection Assay DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• ≥ 18 years old at time of consent
• Patients undergoing a TURBT procedure due to diagnose muscle invasive bladder cancer

You may not qualify if:

• Women who are pregnant or breastfeeding
• 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)

Sponsors & Collaborators

• Animated Dynamics, Inc.: lead

Study Sites (1)

Animated Dynamics, Inc.

Indianapolis, Indiana, 46241, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36522279 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Travis A Morgan, MBA

  Animated Dynamics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Travis A Morgan, MBA

CONTACT

800-963-3313; tmorgan@anidyn.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: June 22, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)