Using PET scans to assess kidney and lung conditions in patients with LAM and TSC
Official title: Feasibility Study of [11C]Acetate Positron Emission Tomography (PET) as an Indicator of Early Response to Rapamycin in Lymphangioleiomyomatosis (LAM) Patients
Run by Brigham and Women's Hospital · NCT05467397 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if special PET scans can help people with kidney and lung problems related to Tuberous Sclerosis Complex better understand their tumors and see how well they respond to treatment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 16 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05467397 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and over diagnosed with LAM or TSC-LAM who have at least one renal angiomyolipoma confirmed by imaging.
✕Probably not a fit
Patients currently undergoing treatment with rapamycin or rapalogs for less than 3 months or more than 1 year may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the use of [11C]acetate positron emission tomography (PET) and computed tomography (CT) as a biomarker for renal angiomyolipomas and pulmonary lymphangioleiomyomatosis (LAM). It aims to determine how effectively this imaging technique can indicate metabolic activity in tumors associated with Tuberous Sclerosis Complex (TSC) and monitor responses to rapamycin treatment. Participants will undergo one or two PET/CT scans over a period of 3 to 6 months at Massachusetts General Hospital, where a small amount of radioactive acetate will be administered intravenously. The study seeks to establish a reliable biomarker that could enhance clinical trials for new therapies targeting these conditions.
Why it matters
Potential benefit: If successful, this study could provide a new method for monitoring treatment responses in patients with LAM and TSC, potentially leading to improved management of these conditions.
How similar studies have gone: Other studies have shown promising results using similar imaging techniques to assess tumor activity, suggesting this approach may be viable.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Carmen P Priolo, MD PhD — Brigham and Women's Hospital
- Study coordinator: Carmen Priolo
- Email: cpriolo@partners.org
- Phone: 8573070783
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.