Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides
Public ClinicalTrials.gov record NCT03789864. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Comparative Analysis of Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy for Human and Canine Mycosis Fungoides
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a single-arm, non-randomized feasibility study designed to find out if the laser light-based imaging test called Biodynamic imaging (BDI) can correctly predict the cutaneous T-cell lymphoma mycosis fungoides (MF) cancer response to chemotherapy treatment. The primary objective is to develop phenotypic profiles of response and non-response to gemcitabine, given at a standard-of-care dose and schedule. A secondary objective is to perform a cross-species analysis of phenotypic responses of human and canine mycosis fungoides to gemcitabine using biodynamic imaging. The study will seek to enroll 10 patients with MF who are planning to receive treatment with gemcitabine given at a standard-of-care (SOC) dose and schedule at Indiana University Simon Cancer Center (IUSCC). All subjects will undergo standardized staging tests, with tumor stage defined according to established guidelines. For the study, three 6-mm x 4-mm dermal punch biopsies from one or more target lesions will be collected prior to treatment initiation and sent to Purdue University researchers for BDI. Objective response for tumor samples treated with gemcitabine in the laboratory will be assessed. Patients with an objective response of complete response (CR) or partial response (PR) that persists during the first 2 treatment cycles will be considered to have responsive cancers, while those failing to meet these criteria will be considered to have resistant cancers. All patients will be considered off-study after completing cycle 2. Accrual is expected to last approximately 24 months.
Study identification
- NCT ID
- NCT03789864
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1 participant
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 6, 2019
- Primary completion
- Apr 30, 2024
- Completion
- Apr 30, 2024
- Last update posted
- May 21, 2024
2019 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Indiana University School of Medicine, Department of Dermatology | Indianapolis | Indiana | 46202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Recently updated Lymphoma, T-Cell, Cutaneous trials
Other public records listing Lymphoma, T-Cell, Cutaneous. Sorted by last update posted; newest first. Not a recommendation.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03789864, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 21, 2024 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03789864 live on ClinicalTrials.gov.