Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03789864 · ClinicalTrials.gov registry record · NA
Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides
A NA study, sponsored by Indiana University.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT03789864: Clinical Trial NA study, sponsored by Indiana University.
NCT03789864 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03789864, a NA study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Dermal punch biopsy samples from subjects' cutaneous mycosis fungoides lesions will be analyzed using ex vivo BDI for sensitivity to gemcitabine. BDI measures intracellular motion patterns (biodynamic profiles) before and after gemcitabine is applied to the sample. Biodynamic profiles associated with poor intercellular organelle motility will be classified as phenotypic responders while those associated with normal intercellular organelle motility will be classified as phenotypic non-responders.
Interventions
- DIAGNOSTIC_TEST Biodynamic imaging (BDI) of mycosis fungoides
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-10-07 |
| Est. Completion | 2024-05-01 |
| Phase | NA |
Why NCT03789864 stopped before completion
NCT03789864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Biodynamic imaging (BDI) of mycosis fungoides is the first listed.
NCT03789864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03789864 about?
NCT03789864 is a clinical study titled "Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides". 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 ...
What is the current status of trial NCT03789864?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2019-10-07. Estimated completion is 2024-05-01.
What interventions are being tested in trial NCT03789864?
The interventions under investigation include: Biodynamic imaging (BDI) of mycosis fungoides (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03789864?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03789864's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI