ClinicalTrials.gov record NCT06224309

Preliminary Assessment of [18F]BL40 in PET/CT Scans

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Oct 10, 2026

A Phase 2 Study to Evaluate the in Vivo Biodistribution, Radiation Dosimetry and a Preliminary Assessment of the Diagnostic Performance of [18F]BL40

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age19 years old to 100 years old
SexAll
LocationCanada
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study evaluates the novel PET tracer 18F-BL40 in people with certain B‑cell and plasma-cell cancers. Each participant will have two PET/CT scans (one with 18F-BL40 and one with standard 18F-FDG); Phase 1 includes extra blood tests and vital-sign checks. Participants receive a phone check the day after 18F-BL40 injection and are followed by chart review for at least six months. The study examines where the tracer goes in the body, radiation doses to organs, safety, and preliminary diagnostic performance compared with 18F-FDG.

What it is studying. Whether the radiotracer 18F-BL40 locates CXCR4-expressing tumors on PET/CT, how it distributes in the body, the radiation dose organs receive, and its safety and preliminary diagnostic performance compared with standard 18F-FDG PET/CT.

What the researchers hope to learn. Scientific goals: measure the biodistribution of 18F-BL40 and absorbed radiation doses to organs and tumors; determine tolerability and short-term safety (adverse events and dose-limiting toxicities); estimate the proportion of participants with 18F-BL40–positive disease; calculate time-integrated activity coefficients for organs and tumors; and compare lesion detection, lesion counts, standardized uptake values (SUVs) and reader confidence between 18F-BL40 and 18F-FDG.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

CXCR4 is type of receptor that has been detected in more than twenty different subtypes of cancers. Most of these cancers are associated with negative symptoms that worsen over time resulting in great disability and poor function. There is a need for novel tracers to image CXCR4-expressing tumors for better detection, staging, and monitoring of aggressive cancers without the need for invasive biopsy procedures that may not always properly capture the extent of a patient's disease. This study looks to assess the safety and efficacy of a novel radiopharmaceutical known as 18F-BL40 through its use in a PET/CT scan. Participants will receive 2 PET/CT scans: 18F-BL40 and 18F-FDG as part of this study.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • 18F-BL40 PET/CT
  • 18F-FDG PET/CT
  • Routine Blood Draw - Phase 1 only

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Age ≥19 years
  • Life expectancy ≥3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Participants with newly diagnosed or documented recurrent malignancy with one of the following cancers:
  • Diffuse large B-Cell lymphoma
  • Multiple myeloma
  • Mantle cell lymphoma
  • Marginal zone lymphoma
  • Chronic lymphocytic leukemia/small cell lymphoma
  • Waldenström Macroglobulinemia

Exclusion criteria

  • Pregnant or breast-feeding
  • Medically unstable (e.g., acute illness, unstable vital signs)
  • Unable to lie supine for the duration of imaging
  • Unable to provide written consent
  • Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
  • Participants with a history of uncontrolled allergic reactions and/or known or expected hypersensitivity to the peptide diagnostic [18F]BL40 or any of its excipients.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This is a prospective registry study to evaluate the diagnostic utility of 18F-BL40 PET/CT to stage patients with CXCR4-expressing tumors, localize sites of tumors and assess safety and biodistribution of this drug in PET/CT scans. Each subject will receive two PET/CT scans, one using 18F-BL40 and the other using 18F-FDG. The 18F-BL40 radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 18F-FDG is considered standard care and has been approved by Health Canada. Follow-up assessments: All subjects will be contacted by phone the day after the injection of 18F-BL40. The subjects will be asked if they experienced any undesirable effects during the 18-72 hours after the administration of 18F-BL40. The local site attending nuclear medicine physician will then make an assessment as to whether these effects are likely related to 18F-BL40 administration. All subjects will be followed for at least 6 months following the 18F-BL40 PET/CT exam. The evaluation will include a chart review of available imaging, laboratory tests, and treatment. The data required can be obtained from a review of the patient's paper and electronic charts, supplemented by telephone contact as needed to complete the information.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You will have two PET/CT imaging visits on separate days: one using the investigational tracer 18F-BL40 and one using the standard tracer 18F-FDG (the FDG visit requires about 6 hours fasting). At each visit an intravenous catheter is placed for the radiotracer injection and you will lie on the scanner for one or more PET/CT scans; in Phase 1 the 18F-BL40 visit includes repeated vital-sign checks, dynamic heart imaging and serial whole‑body scans, and routine blood draws before and within 18–72 hours after 18F-BL40 (blood draws occur only in Phase 1). The day after the 18F-BL40 injection you will receive a phone call asking about any side effects during the 18–72 hour period; the local nuclear medicine physician will assess whether reported effects are likely related. All participants are followed for at least 6 months by chart review of imaging, laboratory tests and treatments, with additional telephone contact as needed to complete the information.

How the study is structured. A prospective observational registry (cohort) in which each participant receives two PET/CT scans on separate occasions: one using the study tracer 18F-BL40 and one using standard 18F-FDG. In Phase 1 (first ~10 patients) the 18F-BL40 exam includes vital-sign checks, an IV catheter, dynamic heart imaging, serial whole-body PET scans, and routine blood tests before and within 18–72 hours after 18F-BL40. In Phase 2 the 18F-BL40 exam uses an IV bolus, a one-hour uptake period, and a 15-minute static scan; no vital signs are recorded per the record. All participants get a phone contact the day after 18F-BL40 injection to ask about adverse effects and are followed by chart review of imaging, labs, and treatment for at least six months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Canada. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Waldenström macroglobulinemia

Clinical trials63 trials listed for Waldenström macroglobulinemiaEvery trial the registry lists for Waldenström macroglobulinemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Waldenström macroglobulinemia researchLatest monthly update: September 2026. Includes: Upfront treatment outcomes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 10, 2024
Primary completion
Mar 15, 2027 (estimated)
Study completion
Sep 15, 2027 (estimated)
Target enrollment
30 participants (estimated)
Last updated on registry
Oct 1, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
British Columbia Cancer Agency

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
PET/CT
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
Life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
ECOG
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
registry
An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
Clinical Trial
A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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