Assessment of Rapamycin Response in LAM Patients Using [11C]Acetate PET Imaging
[11C]acetate
Congenital Abnormalities+23
+ Hamartoma
+ Hemic and Lymphatic Diseases
Diagnostic Study
Summary
Study start date: August 30, 2021
Actual date on which the first participant was enrolled.Lymphangioleiomyomatosis (LAM) is a rare disease affecting women, causing a growth of abnormal cells in the lungs and other organs. These cells have mutations in the TSC1 or TSC2 genes, leading to overactivation of a protein called mTORC1, which stimulates cell growth and metabolism. This results in lung damage, collapsed lungs, and fluid buildup around the lungs. LAM can also cause non-cancerous tumors in the kidneys and lymph vessels. Rapamycin, a drug approved by the FDA, is used to treat LAM and related kidney tumors. However, when treatment stops, the disease may start progressing again. This study aims to find a sensitive and specific way to measure how well the treatment is working and if the disease is progressing, using a type of imaging called [11C]Acetate positron emission tomography (PET) imaging. During the study, participants with LAM will undergo [11C]Acetate PET imaging. This non-invasive scan measures the metabolic activity of LAM lesions. The main goal is to assess how well the [11C]Acetate is taken up by the kidney tumors, using a measurement called Standardized Uptake Value (SUV). This will help determine if [11C]Acetate PET imaging can be used as an effective tool to monitor the response to Rapamycin treatment in LAM patients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.7 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * diagnosis of LAM (or TSC-LAM) * age 18 or over * at least one renal angiomyolipoma (at least 1 cm in each diameter) confirmed by CT or MRI * no prior treatment with rapamycin/rapalogs OR candidate for initiating treatment with rapamycin/rapalogs OR under treatment with rapamycin/rapalogs for minimum 3 months and maximum of 1 year Exclusion Criteria: * under treatment with rapamycin or rapalogs for \< 3 months or \> 1 year * participated in research studies involving radiation exposure (\> 50 mSv/year) in the past 12 months
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location