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:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT05937269
Eligibility Criteria:
Inclusion Criteria:
* Participants must be 18 years of age or older
* Participants must have previously been diagnosed with head and neck cancer and undergone surgery and radiation as part of their standard-of-care treatment plan
* Participants must be ≥ 4 weeks but less than 3 months post-radiation therapy at enrollment
* Female participants of childbearing potential must have a negative urine pregnancy test ≤ 36 hours prior to study drug administration
* Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month after each imaging session
* Male participants must agree to shave facial hair on imaging days
* Participants must be willing and able to independently use the pneumatic compression device at home daily for up to 12 months as directed by study personnel.
Exclusion Criteria:
* Persons who are pregnant or breast-feeding
* Females of child-bearing potential, who do not agree to use an approved contraceptive for one month after each imaging session
* Persons who do not meet inclusion criteria
* Iodine allergy
* Persons with a chest circumference of 150 cm or more
* Uncontrolled hyperthyroidism or parathyroidism (for which an endocrinologist recommends against neck compression)
* Carotid sinus hypersensitivity syndrome
* Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke or amaurosis fugax (monocular visual ischemic symptoms or blindness)
* Symptomatic bradycardia in the absence of a pacemaker or internal jugular venous thrombosis (within 3 months)
* Increased intracranial pressure or other contraindication to internal or external jugular venous compression
* Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6 to 8-weeks post-operative
* Facial or head and neck dermal metastasis
* Acute facial infection (e.g., facial, or parotid gland abscess)
* Heart failure (acute pulmonary edema, decompensated acute heart failure)
* Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
* Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds, or gangrene)
* Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin, or untreated inflammatory skin disease)
* Any condition where increased venous and lymphatic return is undesirable
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05937269
Study Brief:
Protocol Section:
NCT05937269