Status:
UNKNOWN
Hyperpolarized 129Xe MRI for the Assessment of BOS With Late Onset LONIPC
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
Bronchiolitis Obliterans
Eligibility:
All Genders
18-70 years
Brief Summary
The development of bronchiolitis obliterans syndrome (BOS) and other late onset non-infectious pulmonary complications (LONIPCs) following hematopoietic stem cell transplantation (HSCT) is associated ...
Detailed Description
There is mounting evidence suggesting that current practice is failing to provide early detection of LONIPCs, before critical loss of lung function occurs. Furthermore, autopsy series in HSCT patients...
Eligibility Criteria
Inclusion
- For participants who have known LONIPC at enrollment (cross-sectional group):
- Patient is 18 - 70 years old
- Patient has received an allogenic HSCT
- Diagnosed LONIPC
- For participants who have no known LONIPC, but are at risk by virtue of recently-diagnosed cGVHD:
- Patient is 18 - 70 years old
- Patient has received an allogenic HSCT in the last 24 months
- Patient has a new diagnosis of cGVHD within the last 6 months by criteria of:
- Moderate- or severe- cGVHD as per NIH consensus criteria, determined by a treating hematologist or
- cGVHD requiring immunosuppression with prednisone at a dose of \> 0.5mg/kg/day, or alternate steroid-sparing agent
Exclusion
- For participants who have known LONIPC at enrollment (cross-sectional group):
- Age less than 18 years or greater than 70 years of age
- Current smoker (quit in the last 3 months)
- Smoking history greater than 20 pack years
- Presence of contraindications to pulmonary function testing including myocardial infarction within the last one month, hemoptysis, active communicable disease (e.g. TB), inability to follow commands, thoracic/abdominal/eye surgery within the last 3 months, pneumothorax, uncontrolled hypertension (SBP \> 180, DBP \> 110) or pulmonary embolism, other contraindication as determined by technical staff.
- Pregnancy prior to or during study
- In the opinion of the investigator, subject is mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
- Patient has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bio-prosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist/3T Manager)
- In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia
- For participants who have no known LONIPC, but are at risk by virtue of recently-diagnosed cGVHD:
- Age less than 18 years or greater than 70 years of age
- Known history of late onset non-infectious pulmonary complication (LONIPC) related to HSCT
- Current smoker (quit in the last 3 months)
- Smoking history greater than 20 pack years
- Presence of contraindications to pulmonary function testing including myocardial infarction within the last one month, hemoptysis, active communicable disease (e.g. TB), inability to follow commands, thoracic/abdominal/eye surgery within the last 3 months, pneumothorax, uncontrolled hypertension (SBP \> 180, DBP \> 110) or pulmonary embolism, other contraindication as determined by technical staff.
- Pregnancy prior to or during study
- In the opinion of the investigator, subject is mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
- Patient has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bio-prosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist/3T Manager)
- In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia
Key Trial Info
Start Date :
August 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04029636
Start Date
August 1 2019
End Date
November 1 2021
Last Update
July 23 2019
Active Locations (1)
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1
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 1C3