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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04891952
Other study ID # 003
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date August 1, 2031

Study information

Verified date May 2021
Source Animated Dynamics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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].


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date August 1, 2031
Est. primary completion date August 1, 2031
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Onco4D Biodynamic Chemotherapy Selection Assay
Functional precision medicine test to predict response to candidate chemotherapeutic agents

Locations

Country Name City State
United States Animated Dynamics, Inc. Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Animated Dynamics, Inc. Purdue University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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.

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Distribution of chemotherapy regimens prescribed Distribution of chemotherapy regimens prescribed 1 year
Secondary 2 and 5 year Event Free Survival (EFS) 2 and 5 year Event Free Survival (EFS) 2 and 5 years
Secondary radiologic chemotherapy response radiologic chemotherapy response 1 year
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