- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01964625
Positron Emission Tomography - Computed Tomography (PET-CT) Scanning in Chronic Graft Versus Host Disease (cGvHD)
Assessment of Positron Emission Tomography - Computed Tomography (PET-CT) Scanning as a Potential Biomarker to Assess Disease Activity in Chronic Graft Versus Host Disease (GvHD): A Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: PET-CT
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine ability of PET-CT scans to delineate and stage initial chronic GvHD
Time Frame: At initial diagnosis of chronic GvHD
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Assessment to take place after confirmed diagnosis of chronic GvHD but before initiation of therapy
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At initial diagnosis of chronic GvHD
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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PET-CT performed </= 6 months from study PET-CT #1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gordon L Phillips, II, MD, University of Rochester
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32186
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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