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

NCT04891952 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 003
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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\[1-5\].

Conditions

Cancer; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Distribution of chemotherapy regimens prescribed

  1 year

• 2 and 5 year Event Free Survival (EFS)

  2 and 5 years

• radiologic chemotherapy response

  1 year

Interventions

Onco4D Biodynamic Chemotherapy Selection Assay DIAGNOSTIC_TEST

Functional precision medicine test to predict response to candidate chemotherapeutic agents

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• n/a

Sponsors & Collaborators

• Animated Dynamics, Inc.: lead
• Purdue University: collaborator

Study Sites (1)

Animated Dynamics, Inc.

Indianapolis, Indiana, 46241, United States

Location

Related Publications (5)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29760982 BACKGROUND

• 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.

  PMID: 28301634 BACKGROUND

• 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.

  PMID: 26732545 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 19, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): August 1, 2031
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)