Bladder Cancer Clinical Trial
Official title:
Feasibility Study of Motility Contrast Tomography for Predicting Therapeutic Response
NCT number | NCT03739177 |
Other study ID # | 002 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 22, 2017 |
Est. completion date | June 30, 2020 |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Animated Dynamics, Inc. | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Animated Dynamics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective pathological response measured at the time of cystectomy. | 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. | Cystectomy is generally expected to occur 12-16 weeks after biopsy is obtained from a TURBT procedure. |
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