Lymphatic Diseases Clinical Trial
Official title:
Dynamic Contrast Enhanced MR Lymphangiogram Imaging of Lymphatic Anomalies (LA)
Verified date | March 2018 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Lymphatic Anomalies (LA) is characterized by proliferation of lymphatic tissue causing deterioration of pulmonary function. Understanding changes in lymphatic anatomy in these patients is hindered by the difficulty of imaging the lymphatic system. Dynamic Contrast Enhanced MR Lymphangiogram (DCMRL) may be useful in investigating pathological changes in the lymphatic system.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Subjects diagnosed with Lymphatic Anomalies (GLA, KL, Gorham disease) with radiological and or pathological confirmation of lung involvement will be considered for the study. - Girls > 11 y.o. with a negative urine pregnancy test and contraception use. - Registration in the International Lymphangiomatosis and Gorham's Disease Alliance (LGDA) Patient Registry or referral by a physician. Exclusion Criteria: - Subjects with contraindications to contrast enhanced MRI: allergy to gadolinium imaging agents, impaired renal function (GFR<30) and presence of paramagnetic objects. - Claustrophobia or contraindications to sedation/anesthesia - Uncorrectable coagulopathy (bleeding disorders). - Pregnant or lactating females. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Describe lymphatic anatomy of participants with lymphatic anomalies (LA) | The primary endpoint will be the description of lymphatic anatomy assessing if participants have a single or branched Thoracic Duct. | 2 Days | |
Secondary | Development of a classification system for lymphatic flow | Development of a classification system based on retrograde or anterograde flow of lymphatic fluid. | 2 days | |
Secondary | Description of Lymphatic malformations in participants with lymphatic anomalies | Assessing if lymphatic malformation are present or absent in participants with lymphatic anomalies. | 2 days |
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