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

NCT01964625 | Terminated DMC

• 1 other identifier: 32186
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Graft Versus Host Disease

Keywords

Chronic GvHD

Outcome Measures

Primary Outcomes (1)

• To determine ability of PET-CT scans to delineate and stage initial chronic GvHD

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

  At initial diagnosis of chronic GvHD

Secondary Outcomes (1)

• To determine ability of PET-CT scans to document response to chronic GvHD therapy

  PET-CT performed </= 6 months from study PET-CT #1

Study Arms (1)

PET-CT

EXPERIMENTAL

Patients who have a negative routine PET-CT evaluation followed by onset and confirmation in accordance with NIH guidelines, will receive another PET-CT scan prior to initiation of therapy for chronic GvHD.

Other: PET-CT Scan

Interventions

PET-CT Scan OTHER

PET-CT scan will be done at baseline (per standard of care), at onset and confirmation of chronic GvHD and after initiation of therapy to assess response.

PET-CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior allogeneic hematopoietic stem cell transplant (+/- DLI)
• As per current recommendations, no interval from allo HSCT will be required to differentiate acute from chronic Graft versus Host Disease (GvHD)
• Patients must have had negative routine restaging PET-CT scans
• Patients may not have had any more than two weeks' specific treatment for chronic GvHD. (It is recognized that some patients develop chronic GvHD while on immunosuppressive prophylaxis; such patients will remain eligible, even if dose adjustment of these prophylactic agents occurs. The "two week" interval pertains to the use of additional agents in this case.)
• Diagnosis of chronic GvHD must be confirmed. In the usual case, tissue biopsy will be required; however, some chronic GvHD patients do not require tissue biopsy for confirmation. The PI and co-investigator must agree on eligibility.
• Per patient approval by PI and one additional co-investigator
• Informed consent

You may not qualify if:

• Patients with a malignancy not in remission will be excluded.
• Negative routine pregnancy testing. Patients either pregnant or unwilling to use satisfactory contraception (if appropriate) will not be eligible. All female patients must use a highly effective birth control method or a combination of 2 additionally effective birth control methods while in this study. Examples of highly effective birth control are: a condom or a diaphragm with spermicidal jelly, oral, injectable, or implanted birth control, or abstinence.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Gordon L Phillips, II, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: October 17, 2013
• Study Start: November 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 17, 2013

Record last verified: 2013-10

Locations

US (1)