Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07305532
Eligibility Criteria:
Inclusion Criteria:
Participants eligible for inclusion in this study must meet all of the following criteria:
1. Patient understands study procedures and is willing to participate in the study as indicated by the patient's signature.
2. Provision of written, informed consent prior to any study specific procedures.
3. Males and females aged 18 to 85 years.
4. Participant must be able to perform a breath-hold for 16s.
5. Participant has a BMI between 18 and 40
6. Participant must be able to perform reproducible pulmonary function tests (i.e., the 3 best acceptable spirograms have forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater)
7. Participants are judged to be in stable health on the basis of medical history
Exclusion Criteria:
Participants fulfilling any of the following criteria are not eligible for inclusion in this study:
1. Patient has an MR incompatible 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, bioprosthesis, 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).
2. In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI or CT, such as severe claustrophobia.
3. Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit.
4. Participant is unable to perform spirometry maneuvers.
5. Participant is unable to perform MRI and CT breath-hold maneuvers.
6. Participant has a history of chronic or acute respiratory disease
7. FEV1 \<70%
8. Participant has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension (≥160 over ≥100)
9. Participant has a daytime room air oxygen saturation ≤ 92% ± 2% while supine
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07305532
Study Brief:
Protocol Section:
NCT07305532