Using PET scans to assess kidney and lung conditions in patients with LAM and TSC
Feasibility Study of [11C]Acetate Positron Emission Tomography (PET) as an Indicator of Early Response to Rapamycin in Lymphangioleiomyomatosis (LAM) Patients
PHASE1; PHASE2 · Brigham and Women's Hospital · NCT05467397
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 |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Brigham and Women's Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05467397 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promising results using similar imaging techniques to assess tumor activity, suggesting this approach may be viable.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphangioleiomyomatosis, Tuberous Sclerosis Complex