Hyperpolarized 129Xe MRI for the Assessment of BOS With Late Onset LONIPC

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04029636
• Date of registration: 07/06/2019
• Prospective Registration: Yes
• Primary sponsor: Hamilton Health Sciences Corporation
• Public title: Hyperpolarized 129Xe MRI for the Assessment of BOS With Late Onset LONIPC BOS-MRI
• Scientific title: Hyperpolarized 129Xe Magnetic Resonance Imaging for the Early Detection of Bronchiolitis Obliterans Syndrome (BOS) and Other Late Onset Non-infectious Pulmonary Complications (LONIPCs) Following Hematopoietic Stem Cell Transplantation
• Date of first enrolment: August 2019
• Target sample size: 45
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT04029636
• Study type: Observational

Countries of recruitment

Canada

Contacts

• Name: Jane Turner, MD

• Name: Jane Turner, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Bronchiolitis Obliterans

Intervention(s)

Other: Inhaled Hyperpolarized Xenon-129

Primary Outcome(s)

The change detected in FEV1/FVC ratio and RV/TLC ratio in cross-sectional and prospectively followed cohorts. [Time Frame: PFTs will be performed as clinically indicated, which in this study population will be every three months for two years.]

The change detected in Apparent Diffusion Coefficients (ADC) on 129Xe MRI imaging in cross-sectional and prospectively followed cohorts. [Time Frame: MRIs will be performed every three months for one year.]

The change detected in Ventilation Defect Percent (VDP) on 129Xe MRI imaging in cross-sectional and prospectively followed cohorts. [Time Frame: MRIs will be performed every three months for one year.]

The change detected in DLCO divided by alveolar volume (VA) [DLCO/VA, or transfer coefficient of the lung for carbon monoxide, KCO] in cross-sectional and prospectively followed cohorts. [Time Frame: PFTs will be performed as clinically indicated, which in this study population will be every three months for two years.]

The change detected in forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), total lung capacity (TLC), and residual volume (RV) in cross-sectional and prospectively followed cohorts. [Time Frame: Pulmonary Function Tests (PFTs) will be performed as clinically indicated, which in this study population will be every three months for two years.]

The change detected in Signal-to-noice Ration (SNR) on 129Xe MRI imaging in cross-sectional and prospectively followed cohorts. [Time Frame: MRIs will be performed every three months for one year.]

The change detected in forced oscillometry technique (FOT) in cross-sectional and prospectively followed cohorts. [Time Frame: Oscillometry will be recorded every three months for one year.]

The change detected in diffusion capacity of the lung for carbon monoxide (DLCO) and DLCO corrected for hemoglobin in cross-sectional and prospectively followed cohorts. [Time Frame: PFTs will be performed as clinically indicated, which in this study population will be every three months for two years.]

Secondary Outcome(s)

Change in airway resistance and reactance over time quantified by FOT [Time Frame: Oscillometry will be recorded every three months for one year.]

Development of clinical outcomes of death, hospitalization for respiratory cause, or respiratory failure. [Time Frame: Outcomes will be documented over the study's duration (2 years).]

Development of Bronchiolitis Obliterans Syndrome (BOS) [Time Frame: Development of BOS will be documented over the study's duration (2 years).]

Secondary ID(s)

5996

Source(s) of Monetary Support

Please refer to primary and secondary sponsors