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PET scans may reveal hidden leukemia spots before CAR t treatment

NCT ID NCT05969002

Knowledge-focused Sponsor: National Cancer Institute (NCI) 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 13 times

Summary

This pilot study tested whether PET-CT scans can detect leukemia that has spread outside the bone marrow in patients with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia (ALL). Ten participants received a PET scan before and after CAR T-cell therapy. The goal was to see how common these hidden spots are and whether they affect treatment success.

What this could mean

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

Active substance
18F-FDG PET-CT imaging
What this could lead to
If successful, this imaging approach could help doctors better detect hidden leukemia before CAR T-cell therapy, potentially improving treatment outcomes.
What could go wrong
This is a very small pilot study with only 10 participants, so results may not apply to all patients. The imaging is for observation only and does not directly treat the disease.

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.

Participants

10 people

The number who actually took part.

Started

Aug 2023

Finished

Dec 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Who is studied

Primary care clinic

Ages

5 to 39 years

Sex

Anyone

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: Participants must have a B cell ALL (inclusive of CML with ALL transformation) * Age: 5-39 years * All participants \>=18 years old with relapsed/refractory B cell ALL potentially proceeding to CAR therapy at the NIH, or * Any participant \<18 potentially proceeding to CAR therapy at the NIH with a clinical indication for FDG PET-CT prior to CAR infusion: * History of prior EMD * History of post-HSCT relapse * Clinical signs or incidental findings suspicious for EMD * Peripheral disease out of proportion of bone marrow disease burden * Participants who are breastfeeding or plan to breastfeed must agree to discontinue/postpone breastfeeding within 24 hours of any PET-CT scan * Ability and willingness of participant or Legally Authorized Representative (LAR) to co-enroll on protocol 10-C-0086 "Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies". * Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Pregnant individuals are excluded from this study * History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study (e.g., FDG injection)

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia B-cell acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence

As listed by the trial registrant

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

Acute lymphoblastic leukemia B cell Relapsed/refractory

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

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