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Onco4D(TM) Biodynamic Chemotherapy Selection for Breast Cancer Patients

NCT03164863 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2020-01-13

No results posted yet for this study

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 breast 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 breast and other cancer patients.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Animated Dynamics, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-06
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03164863 on ClinicalTrials.gov