Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides (BDI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03789864|
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment|
|Lymphoma, T-Cell, Cutaneous Mycosis Fungoides||Diagnostic Test: single-arm, non-randomized Biodynamic imaging (BDI)|
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Comparative Analysis of Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy for Human and Canine Mycosis Fungoides|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||July 31, 2021|
single-arm, non-randomized Biodynamic imaging (BDI)
Single-arm, non-randomized, Biodynamic phenotypic profiling of cancer (specifically, mycosis fungoides) therapy, gemcitabine . Standard of Care treatment with gemcitabine in this setting is 1200 mg/m2 as a 30 minute infusion given intravenously on days 1, 8, and 15 of every 28-day treatment cycle. Standard dose reductions are expected in patients experiencing unacceptable toxic effects of treatment. All subjects will undergo standardized staging tests, with tumor stage defined according to established guidelines. For this study, three 6-mm x 4-mm dermal punch biopsies from one or more target lesions will be collected prior to treatment initiation and submitted for Biodynamic imaging (BDI). All patients will be considered off-study after completing cycle 2.
Diagnostic Test: single-arm, non-randomized Biodynamic imaging (BDI)
Skin punch biopsy samples from cutaneous lesions will be profiled for sensitivity to gemcitabine using ex vivo Biodynamic imaging (BDI). The primary clinical outcome assessed will be objective response to chemotherapy after 2 cycles of treatment.
Other Name: mycosis fungoides
- Number of Participants with an objective clinical response of MF to gemcitabine chemotherapy [ Time Frame: After the completion of 2 cycles of treatment for each study participant, i.e. after day 56 of study for each individual participant ]Patients will be classified as responders versus non-responders based on well defined measures of complete response (responder), partial response (responder), stable disease (non-responder) or progressive disease (non-responder) as outlined in the study protocol.
- Number of Participants with phenotypic ex-vivo tumor cell response to gemcitabine chemotherapy [ Time Frame: Day 1 of study for each individual participant ]Intracellular motion patterns (biodynamic profiles) are measured by biodynamic imaging technique. Biodynamic profiles associated with poor intercellular organelle motility will be classified as phenotypic responders.
- Percent of individual biodynamic profiles with cellular response (outcome 2) correlating with individual clinical response (outcome 1). [ Time Frame: After day 56 of study for each individual participant ]Correlation against discrete patient outcome classifications (response vs. non-response) will be made to individual biodynamic profiles associated with cellular response vs. non-response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789864
|Contact: Lawrence A Mark, MD,PhDfirstname.lastname@example.org|
|Contact: Flossy Lincoln, MPH,CCRPemail@example.com|
|United States, Indiana|
|Indiana University School of Medicine, Department of Dermatology||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Lawrence A Mark, MD, PhD 317-274-7705 firstname.lastname@example.org|
|Contact: Flossy Lincoln, MPH, CCRP 3172748750 email@example.com|
|Principal Investigator: Lawrence A Mark, MD, PhD|
|Sub-Investigator: Kristin E Hoffmann, MD|
|Sub-Investigator: Jose M Azar, MD|
|Sub-Investigator: Uptal P Davé, MD|
|Sub-Investigator: Michael J Robertson, MD|
|Principal Investigator:||Lawrence A Mark, MD, PhD||Indiana University|