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[11C]acetate for Tuberous Sclerosis and Lymphangioleiomyomatosis
This trial will assess whether [11C]acetate PET/CT can be used as a biomarker to track disease in patients with TSC-related renal angiomyolipomas and pulmonary LAM and to measure early response to rapamycin in LAM patients.
- Tuberous Sclerosis
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You must be 18 years old or older.You have at least one kidney tumor that is at least 1 cm in size confirmed by a CT or MRI scan.You have been diagnosed with LAM or TSC-LAM.You have not been treated with rapamycin/rapalogs before, or you are eligible to start treatment with rapamycin/rapalogs, or you have been treated with rapamycin/rapalogs for at least 3 months but no more than 1 year.You have been taking rapamycin or similar medications for less than 3 months or more than 1 year.You have been diagnosed with LAM (or TSC-LAM).You have at least one kidney tumor that is at least 1 centimeter in size, confirmed by a CT or MRI scan.You have not been treated with rapamycin/rapalogs before, or you are eligible to start treatment with rapamycin/rapalogs, or you have been treated with rapamycin/rapalogs for at least 3 months but no more than 1 year.You have been in other studies where you were exposed to a lot of radiation in the past year.
- Group 1: Patients will undergo [11C]acetate PET/CT
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the scope of the subjects being treated within this research project?
"Affirmative. Clinicaltrials.gov records that this research experiment, which was initially made public on August 30th 2021, is currently seeking volunteers. 16 individuals must be recruited from 1 site to complete the trial."
Are there any openings available in this experiment for participants?
"Affirmative. The information found on clinicaltrials.gov states that this study is recruiting participants, with the initial posting occurring August 30th 2021 and a recent update from July 20th 2022. Currently, 16 people need to be recruited at one site."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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