Measuring the Impact of Onco4D® Guidance on Chemotherapy Selection and Outcomes

Measuring the Impact of Onco4D® Guidance

Millions of cancer patients each year receive chemotherapy causing 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.

The Onco4D® chemotherapy selection assay has recently emerged as means to measure the response of intact tumor biopsies to applied therapeutics by using Doppler detection of infrared light scattered from intracellular motions inside living tissue (known as Motility Contrast Tomography or MCT). Several studies have shown this phenotypic profiling technique to offer high accuracy predicting response and resistance to chemotherapy[1-5].

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Chemotherapy Effect
• Intervention / Treatment: Diagnostic test: Onco4D Biodynamic Chemotherapy Selection Assay

Detailed Description

SPECIFIC AIMS The scope of this study is to measure the impact of Onco4D® therapy guidance on treatment and outcomes among cancer patients for whom the test is ordered.

PRIMARY ENDPOINT: Difference in pathologic complete response (pCR) to neoadjuvant chemotherapy among recipients of Onco4D® guided therapy as compared to baseline unguided pCR rates.

SECONDARY ENDPOINTS: Difference in distribution of chemotherapy regimens among recipients of Onco4D® guided therapy as compared to baseline unguided regimens, adjuvant chemotherapy response, 2 and 5 year event free survival (EFS), pre- and post-chemotherapy cancer staging scores (TNM, ACJJ, RCB, etc..), radiologic chemotherapy response, additional exploratory endpoints as appropriate

RESEARCH DESIGN AND METHODS

STUDY DESIGN: Non-randomized multi-center prospective outcomes registry

PARTICIPANT IDENTIFICATION: Cancer patients of all races and ethnic groups are eligible for this registry. All patients treated at participating sites and meeting the inclusion criteria will be offered the opportunity to participate in the registry. Potential participants will be presented with the purpose of the study and the potential risks and benefits of participation. Participants will be considered registered to the study upon receipt of a signed informed consent statement. Registration information will be maintained by the Principal Investigator. All participants will be assigned a unique study ID.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46241
      • Animated Dynamics, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients of all races and ethnic groups are eligible for this registry. All patients treated at participating sites and meeting the inclusion criteria will be offered the opportunity to participate in the registry. Potential participants will be presented with the purpose of the study and the potential risks and benefits of participation. Participants will be considered registered to the study upon receipt of a signed informed consent statement. Registration information will be maintained by the Principal Investigator. All participants will be assigned a unique study ID.

Description

Inclusion Criteria:

1. Histologically proven cancer of any type
2. Onco4D® test ordered by treating physician
3. Ability to understand and willingness to sign an informed consent
4. ≥ 18 years old at time of consent

Exclusion Criteria:

n/a

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic complete response (pCR) to neoadjuvant chemotherapy	Difference in pathologic complete response (pCR) to neoadjuvant chemotherapy among recipients of Onco4D® guided therapy as compared to baseline unguided pCR rates	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of chemotherapy regimens prescribed	Distribution of chemotherapy regimens prescribed	1 year
2 and 5 year Event Free Survival (EFS)	2 and 5 year Event Free Survival (EFS)	2 and 5 years
radiologic chemotherapy response	radiologic chemotherapy response	1 year

Collaborators and Investigators

• Sponsor: Animated Dynamics, Inc.
• Collaborators: Purdue University

Publications and helpful links

General Publications

• Whitacre E, Manahan E, Burak W, Morgan T, An R, Loesch D: Abstract P3-11-17: A novel biodynamic imaging assay predicts success or failure of neoadjuvant chemotherapy in breast cancer patients. Cancer Research 2019, 79(4 Supplement):P3-11-17.
• Turek JJ, Nolte DD, An R: Abstract 2849: Biodynamic imaging predicts response of breast cancer patients to neoadjuvant chemotherapy. Cancer Research 2018, 78(13 Supplement):2849.
• Choi H, Li Z, Sun H, Merrill D, Turek J, Childress M, Nolte D. Biodynamic digital holography of chemoresistance in a pre-clinical trial of canine B-cell lymphoma. Biomed Opt Express. 2018 Apr 17;9(5):2214-2228. doi: 10.1364/BOE.9.002214. eCollection 2018 May 1.
• Sun H, Merrill D, An R, Turek J, Matei D, Nolte DD. Biodynamic imaging for phenotypic profiling of three-dimensional tissue culture. J Biomed Opt. 2017 Jan 1;22(1):16007. doi: 10.1117/1.JBO.22.1.016007.
• Merrill D, An R, Sun H, Yakubov B, Matei D, Turek J, Nolte D. Intracellular Doppler Signatures of Platinum Sensitivity Captured by Biodynamic Profiling in Ovarian Xenografts. Sci Rep. 2016 Jan 6;6:18821. doi: 10.1038/srep18821.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): August 1, 2031
• Study Completion (Anticipated): August 1, 2031

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 003 (033)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No