Recruiting

Onco4D TM

Sponsor:

Animated Dynamics, Inc.

Code:

NCT03164863

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Onco4D Biodynamic Chemotherapy Selection Assay

Study Details

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 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

Breast Cancer

Study ID

NCT03164863

Start date

Mar 6, 2017

Status verified date

Jan, 2020

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

INCLUSION CRITERIA: To be eligible for the study, women 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 with all or any combination of the following indications to include diagnosis of breast cancer, abnormal mammography, abnormal ultrasound, with or without abnormal clinical findings as well as abnormal clinical findings without an imaging correlate.

EXCLUSION CRITERIA: To be eligible for the study, women 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)

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

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 measure

  • Objective pathological response measured at the time of surgery. [ Time Frame: 12-16 weeks after tumor biopsy ]

Central Contacts and Locations

Central contacts

Travis A Morgan, MBA

800-963-3313tmorgan@anidyn.com

Locations

Animated Dynamics, Inc.

Recruiting

Indianapolis, Indiana, United States, 46241

Contacts

Travis D Morgan

800-963-3313tmorgan@anidyn.com

Principal Investigator:

Ran An, Ph.D.

More Information

Sponsor

Animated Dynamics, Inc.

Last update posted

Jan 13, 2020

Last verified

Jan, 2020

Keywords

  • Neoadjuvant Chemotherapy, Triple Negative Breast Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Animated Dynamics, Inc. on 2020-01-13.