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New PET scan could reveal early drug response in rare lung disease

NCT ID NCT05467397

Diagnosis Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a special PET scan using [11C]acetate can detect early signs that the drug rapamycin is working in people with lymphangioleiomyomatosis (LAM), a rare lung disease. Seven adults with LAM and kidney tumors will get one or two scans over 3–6 months. The goal is to see if the scan can serve as a quick, non-invasive biomarker of treatment response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
[11C]acetate (a radioactive tracer used in PET scans)
What this could lead to
If successful, this PET scan could provide a new way to quickly see if rapamycin is working in LAM patients, helping doctors adjust treatment sooner.
What could go wrong
This is a very small, early-phase study with only 7 participants, so results may not apply to everyone. The scan is experimental and not yet proven to be reliable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

7 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lymphangioleiomyomatosis tuberous sclerosis tuberous sclerosis 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphangioleiomyomatosis Tuberous sclerosis complex

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

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