Onco4D(TM) Biodynamic Chemotherapy Selection for Breast Cancer Patients

NCT03164863 | Unknown

• 1 other identifier: 001-B
• 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 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

Keywords

Neoadjuvant Chemotherapy, Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective pathological response measured at the time of surgery.

  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.

  12-16 weeks after tumor biopsy

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

Women of all races and ethnic groups are eligible for this study. Patients will be recruited from participating sites after interpretation of mammography or other radiological screening, but prior to performance of a core, incision, or excision breast biopsy per routine care guidelines (Cohort A) or, optionally, after a diagnosis of cancer has been made and the patient has consented to a secondary biopsy procedure specifically for the purpose of this study (Cohort B).

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 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.

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

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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: May 22, 2017
• First Posted: May 24, 2017
• Study Start: March 6, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)