Clinical Trial: Positron Emission Tomography - Computed Tomography (PET-CT) Scanning in Chronic Graft Versus Host Disease (cGvHD)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Assessment of Positron Emission Tomography - Computed Tomography (PET-CT) Scanning as a Potential Biomarker to Assess Disease Activity in Chronic Graft Versus Host Disease

Brief 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 tom

Detailed Summary:
Sponsor: University of Rochester

Current Primary Outcome: To determine ability of PET-CT scans to delineate and stage initial chronic GvHD [ Time Frame: At initial diagnosis of chronic GvHD ]

Assessment to take place after confirmed diagnosis of chronic GvHD but before initiation of therapy


Original Primary Outcome: Same as current

Current Secondary Outcome: To determine ability of PET-CT scans to document response to chronic GvHD therapy [ Time Frame: PET-CT performed </= 6 months from study PET-CT #1 ]

Therapy for chronic GvHD can be standard of care or investigational. Maximal response to treatment is defined as stability on two occasions >/= one month apart; PET-CT to be performed within two weeks of this assessment. Initial PET-CT at diagnosis will be used as the comparison.


Original Secondary Outcome: Same as current

Information By: University of Rochester

Dates:
Date Received: December 1, 2010
Date Started: November 2010
Date Completion:
Last Updated: October 14, 2013
Last Verified: October 2013