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NCT01964625 · ClinicalTrials.gov registry record · NA
Positron Emission Tomography - Computed Tomography (PET-CT) Scanning in Chronic Graft Versus Host Disease (cGvHD)
A NA study, sponsored by University of Rochester.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT01964625: Clinical Trial NA study, sponsored by University of Rochester.
NCT01964625 is a NA study that was terminated before completion, run by University of Rochester. 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
NCT01964625, a NA study, was terminated before completion, sponsored by University of Rochester.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
Graft versus Host Disease (GvHD), in both its acute and chronic forms, is the major intrinsic complication of allogeneic hematopoeitic stem cell transplant (allo-HSCT). Moreover, chronic GvHD may be regarded as a "late effect" of cancer therapy, and the severity of chronic GvHD is the chief determinant of long-term survival following allo-HSCT. Unfortunately, the investigators understanding (and thus management) of chronic GvHD is not optimal; a recent NIH Consensus Conference has defined inadequacies in virtually all facets of chronic GvHD management. Notably for this study, the lack of suitable biomarkers compromises diagnosis, staging and therapeutic response evaluation of chronic GvHD - and also hinders better understanding of the biology of this process. In particular, the activity of chronic GvHD is often difficult to discern, potentially causing either undertreatment, with the risk of morbidity and/or mortality due to uncontrolled chronic GvHD, or possibly overtreatment, with potent ISTs causing unnecessary toxicity. Obviously, the development of reliable biomarkers of chronic GvHD activity would be a very useful advance in addressing this problem, as well as other facets of management not addressed due to certain limitations, as detailed herein. Potentially, certain imaging technologies could address this problem. To date, imaging technology has been used only sporadically in chronic GvHD and is not an integral part of routine assessments. However, and despite its nonspecific nature, certain "inflammatory" features of some chronic GvHD cases, plus clinical similarity to certain autoimmune diseases in which functional imaging has been tested in research trials - (and perhaps notably), a limited experience in acute GvHD - the investigators postulate that Positron emission tomography - computed tomography (PET-CT) scans may be useful as a biomarker of disease activity in chronic GvHD. This protocol is an initial effort to that end.
Primary Outcome
Assessment to take place after confirmed diagnosis of chronic GvHD but before initiation of therapy
Interventions
- OTHER PET-CT Scan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-08 |
| Phase | NA |
Why NCT01964625 stopped before completion
NCT01964625 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 PET-CT Scan is the first listed.
NCT01964625 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01964625 about?
NCT01964625 is a clinical study titled "Positron Emission Tomography - Computed Tomography (PET-CT) Scanning in Chronic Graft Versus Host Disease (cGvHD)". Graft versus Host Disease (GvHD), in both its acute and chronic forms, is the major intrinsic complication of allogeneic hematopoeitic stem cell transplant (allo-HSCT). Moreover, chronic GvHD may be regarded as a "late effect" of cancer therapy, and the severity of chronic GvHD is the chief determin...
What is the current status of trial NCT01964625?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2010-11. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01964625?
The interventions under investigation include: PET-CT Scan (OTHER).
Who is sponsoring clinical trial NCT01964625?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01964625'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
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