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

Cancer Clinical Trial

Official title:

Measuring the Impact of Onco4D® Guidance

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04891952
• Other study ID #: 003
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cancer
• Chemotherapy Effect

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