Clinical trial · Observational
Onco4D(TM) Biodynamic Chemotherapy Selection for Bladder Cancer Patients
Feasibility Study of Motility Contrast Tomography for Predicting Therapeutic Response
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 bladder 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 bladder and other cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Onco4D Biodynamic Chemotherapy Selection Assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective pathological response measured at the time of cystectomy.
- timeFrame
- Cystectomy is generally expected to occur 12-16 weeks after biopsy is obtained from a TURBT procedure.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA: To be eligible for the study, participants must meet the following criteria: 1. 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 2. ≥ 18 years old at time of consent 3. Patients undergoing a TURBT procedure due to diagnose muscle invasive bladder cancer EXCLUSION CRITERIA: To be eligible for the study, participants must not be or have any of the following: 1. Women who are pregnant or breastfeeding 2. 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)
References
Publications (1)
- DERIVEDLaviana AA, Schiftan EG, Mashni JW, Large MC, Kaimakliotis HZ, Nolte DD, Turek JJ, An R, Morgan TA, Chang SS. Biodynamic prediction of neoadjuvant chemotherapy response: Results from a prospective multicenter study of predictive accuracy among muscle-invasive bladder cancer patients. Urol Oncol. 2023 Jun;41(6):295.e9-295.e17. doi: 10.1016/j.urolonc.2022.11.017. Epub 2022 Dec 13. PMID 36522279