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Lymphangioleiomyomatosis clinical trials

View clinical trials related to Lymphangioleiomyomatosis.

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NCT ID: NCT06405997 Recruiting - Clinical trials for TSC-associated Lymphangioleiomyomatosis

The Genotype and Phenotype of Lymphangioleiomyomatosis

Start date: May 10, 2024
Phase:
Study type: Observational

This study aims to differentiate between sporadic Lymphangioleiomyomatosis and Tuberous Sclerosis Complex-associated Lymphangioleiomyomatosis.

NCT ID: NCT06160310 Recruiting - Clinical trials for Tuberous Sclerosis Complex

Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry (TSC-LAM Registry)

Start date: July 1, 2023
Phase:
Study type: Observational [Patient Registry]

This study is an observational registry designed to gather information about Tuberous Sclerosis Complex (TSC) and Lymphangioleiomyomatosis (LAM) in pregnant women and their child.

NCT ID: NCT05727852 Enrolling by invitation - Cystic Fibrosis Clinical Trials

Breath Analysis and Arterial Stiffness in Patients With Respiratory Diseases

Start date: January 30, 2023
Phase:
Study type: Observational

Assessment of cardiovascular disorders using echocardiography and arterial stiffness; comparative noninvasive assessment of volatile organic compound (eVOC) exhale breath patterns in patients with different chronic respiratory diseases with age and gender-matched healthy adults in order to identify a disease-specific exhaled eVOCs profiles and markers of respiratory and cardiovascular disorders.

NCT ID: NCT05676099 Recruiting - Tuberous Sclerosis Clinical Trials

TSC Biosample Repository and Natural History Database

Start date: January 2016
Phase:
Study type: Observational [Patient Registry]

The TSC Biosample Repository collects and stores samples of blood, DNA, and tissues that scientists can request to use in their research. The samples we collect are all linked to clinical data in the TSC Natural History Database. The TSC Natural History Database captures clinical data to document the impact of the disease on a person's health over his or her lifetime. This data may be collected retrospectively or prospectively.

NCT ID: NCT05467397 Recruiting - Clinical trials for Tuberous Sclerosis Complex

Feasibility of [11C]Acetate-PET in LAM and TSC

Start date: August 30, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study aims to assess [11C]acetate positron emission tomography (PET)/computed tomography (CT) as a biomarker for renal angiomyolipomas and pulmonary lymphangioleiomyomatosis (LAM) and an early biomarker of response to rapamycin in LAM patients. [11C]Acetate is a radioactive form of acetate, a nutrient commonly processed in our body's cells to generate fat and energy. Preclinical studies support the hypothesis that TSC tumors enhance lipid synthesis compared to normal tissues, suggesting that quantification of [11C]acetate in these tumors by PET/CT may provide a metabolic biomarker of disease. Participants in the study will undergo 1 or 2 PET/CT scans over 3 to 6 months at the Massachusetts General Hospital (Boston, MA). [11C]acetate is administered through an intravenous catheter. This small amount of radioactivity is short-lived and eliminated from the body within a few hours.

NCT ID: NCT05323370 Completed - Clinical trials for Tuberous Sclerosis Complex

Lymphangioleiomyomatosis, a Study on Cathepsin K

LAM-CAK
Start date: May 31, 2022
Phase:
Study type: Observational

This is a physiopathological case-control, non-interventional, monocentric study of adult patients with lymphangioleiomyomatosis. The controls are patients followed in neurology at the CHU of Tours for a tuberous sclerosis complex without lymphangioleiomyomatosis, the healthy volunteers are women with neither pulmonary nor renal pathology and recruited at the clinical investigation centre of the CHU of Tours.

NCT ID: NCT05190627 Recruiting - Clinical trials for Lymphangioleiomyomatosis

Effect of Loratadine in Lymphangioleiomyomatosis

LORALAM
Start date: November 1, 2021
Phase: Phase 2
Study type: Interventional

INTRODUCTION: LAM is a rare and lethal disease characterized by progressive cystic lung destruction. Inhibition of mTOR with rapamycin is the current standard of care (SOC), which can slow-down disease. Plasma major histamine metabolite (Methylimidazoleacetic acid [MIAA]) is increased in LAM. Loratadine is a histamine receptor antagonist (HR1), which inhibits LAM cell proliferation. Therefore, a novel phase-II clinical trial for assessing safety and potential benefits of loratadine in LAM has been initiated. METHODS: LORALAM clinical trial, phase-II, double-blind, randomized, placebo controlled, parallel-group, multicentre study initiates recruitment in July 2020. Enrollment plan includes 62 subjects with LAM on treatment with rapamycin ≥3 months, randomized 1:1 to add oral loratadine 10mg/day or placebo, once daily, for 52 weeks. Recruitment will end in June 2021. The primary endpoints are 1) to assess the safety profile of loratadine associated with rapamycin, 2) lung function decline after 52 weeks of treatment. The secondary endpoints are a) quality of life and progression free-survival time, b) changes in the established LAM serum biomarker VEGFD, c) the utility of MIAA for monitoring disease progression and biological treatment effect. ETHICS AND DISSEMINATION: The study will be carried out in accordance with Good Clinical Practice guidelines, Declaration of Helsinki principles, and each ethical committee. This clinical trial contemplates the possibility of increasing the number of centers and including patients from patient support groups (LAM foundation, AELAM)

NCT ID: NCT05087134 Not yet recruiting - Clinical trials for Lymphangioleiomyomatosis

Characterizing LAM With 11C-Choline PET/CT

Start date: November 2021
Phase: Early Phase 1
Study type: Interventional

It was reported that TSC2-deficient cells enhance phosphatidylcholine synthesis via the Kennedy pathway. 11C-Choline can reflect the metabolic process of choline in vivo by intravenous injection. The purpose of this study is the ability of 11C-Choline PET/CT to evaluate the baseline condition of LAM patients and the efficacy of rapamycin after treatment.

NCT ID: NCT04577937 Recruiting - Sleep Disorder Clinical Trials

Sleep Patterns in Patients Affected by Lymphangioleiomiomatosis

Start date: June 30, 2020
Phase: N/A
Study type: Interventional

Lymphangioleiomyomatosis (LAM) is a rare and progressive pulmonary disease of unknown etiology that almost exclusively affects women. It is characterised by cystic radiological lung pattern and by the possible presence of angiomyolipomas in other sites or organs. Functionally LAM is associated with airway obstruction or restriction and progressive hypoxemia up to chronic respiratory failure. There are no studies, so far, which have investigated whether during sleep these patients show changes in the sleep profile and gas exchange and if these changes are related to disease severity. Aim of the study, prospective and pilot, is to evaluate whether the physiological modification of respiratory mechanics during sleep is associated with polysomnographic alterations in LAM.

NCT ID: NCT04388371 Completed - Clinical trials for Lymphangioleiomyomatosis (LAM)

Glutamine PET Imaging in LAM

Start date: October 18, 2019
Phase: Phase 1
Study type: Interventional

In this study, subjects with spontaneous or tuberous sclerosis complex associated lymphangioleiomyomatosis (LAM) who have not been started on therapy with mTOR inhibitors such as sirolimus or everolimus to undergo a PET/CT scan using an novel PET tracer that may better evaluate disease activity in LAM subjects both before and after the initiation of mTOR inhibitor therapy will be enrolled. The procedure for each scan will be similar, involving one administration of the novel tracer C11-glutamine followed by a whole body PET/CT scan.