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[11C]Acetate-PET for Tuberous Sclerosis and Lymphangioleiomyomatosis
Phase 1 & 2
Recruiting
Led By Carmen P Priolo, MD PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study Summary
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.
Who is the study for?
Adults with Tuberous Sclerosis or Lymphangioleiomyomatosis who have at least one renal angiomyolipoma confirmed by imaging. They can be new to rapamycin treatment, about to start it, or have been on it for 3 months to a year but not more. Those recently exposed to high radiation in other studies cannot participate.Check my eligibility
What is being tested?
[11C]acetate-PET/CT scans are being tested as potential biomarkers for disease activity in patients with renal angiomyolipomas and pulmonary LAM. The study will see if these scans can help track the tumors' response early on when treated with rapamycin.See study design
What are the potential side effects?
Since [11C]acetate is radioactive, there's a risk of exposure to radiation; however, it's short-lived and expected to leave the body within hours. There may also be typical risks associated with PET/CT scans like discomfort from the IV catheter.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acetate
Secondary outcome measures
Feasibility of [11C]acetate PET as a biomarker of mTORC1 inhibition in LAM/TSC proliferative lesions
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients will undergo [11C]acetate PET/CTExperimental Treatment1 Intervention
Patients will undergo a single [11c]acetate PET scan OR Patients will undergo an [11c]acetate PET scan, initiate treatment with rapamycin or rapalogs and receive a second [11c]acetate PET scan 3 or 4 months after starting the treatment.
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,608 Previous Clinical Trials
11,469,861 Total Patients Enrolled
3 Trials studying Lymphangioleiomyomatosis
54 Patients Enrolled for Lymphangioleiomyomatosis
Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,198,339 Total Patients Enrolled
Carmen P Priolo, MD PhDPrincipal InvestigatorBrigham and Women's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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 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 been taking rapamycin or similar medications for less than 3 months or more than 1 year.You have been in other studies where you were exposed to a lot of radiation in the past year.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.
Research Study Groups:
This trial has the following groups:- Group 1: Patients will undergo [11C]acetate PET/CT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Lymphangioleiomyomatosis Patient Testimony for trial: Trial Name: NCT05467397 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I want to help with finding a cure for Lymphangioleiomyomatosis. To give hope to all the women diagnosed with this rare disease instead of them being handed a death sentence.
PatientReceived 1 prior treatment
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