NCT07066436Not yet recruitingEarly phase 1
ImmunoMRI for Assessment of Tumor-associated Macrophages
ImmunoMRI for Assessment of Tumor-associated Macrophages: A Prospective Study in Patients With Diffuse Large B-cell Lymphoma Receiving CAR T-cell or Bispecific Antibody Therapy
Source: ClinicalTrials.gov · Last updated 15 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
About 35% of patients with a type of blood cancer called diffuse large B-cell lymphoma don't respond well to standard treatment or their cancer comes back. When this happens, newer treatments like CAR T-cell therapy (using modified immune cells) or bispecific antibodies (special proteins that help the immune system fight cancer) are an option. However, these treatments are only successful in about half the patients. It is currently difficult to predict which patients will respond to these treatments or experience serious side effects. This makes it hard to choose the best treatment plan for a given patient. In this project, a special type of magnetic resonance imaging (MRI) scan will be used to track immune cells called macrophages that live around tumors. These cells can either help fight cancer or help cancer grow. By understanding how these cells behave, it may be possible to predict treatment success. The MRI technique involves injecting an iron-based substance called ferumoxytol, which can be used as an MRI contrast agent, into patients' veins. This contrast agent gets absorbed by the macrophages, making them visible on MRI scans throughout the entire body - not just one tumor spot. Sixty patients will be scanned before and after treatment (30 getting CAR T-cells, 30 getting bispecific antibodies), and results will be compared with tissue samples. The goals are to predict which patients will go into complete remission, predict who will survive longer without cancer progression, and identify patients at risk for serious side effects like cytokine release syndrome. If successful, this imaging technique could help to personalize treatment choices, potentially improving outcomes while avoiding unnecessary toxicity in patients who will not benefit from these intensive therapies.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 24 Jun 2025
- Start date
- Oct 2025
- Primary completion date
- Mar 2028
- Lead sponsor
- Medical University of Vienna
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT07066436
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 60
- From Oct 2025 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Impaired renal function / renal insufficiency
- Known contraindication to MRI (per MRI Safety Guidelines, or conditions such as claustrophobia)
- Known hypersensitivity to ferumoxytol or any of its components, or history of allergic reaction to any intravenous iron product.
Age
- Age below the specified minimum of 18 years.
Other
- Clinically confirmed pregnancy for women, or breast-feeding women; for pre-menopausal women who do not use hormonal contraception, a pregnancy test with a negative result will be required.
- Any type of anemia at baseline (due to potentially altered ferumoxytol uptake)
Who the study is looking for
- Pathology-proven relapsed/refractory DLBCL
- Evidence of at least one anatomic site of tumor involvement on most recent prior imaging, e.g. CT, MRI, PET, or ultrasound, reflecting R/R DLBCL.
- Ability to understand the study goals or outline and to give written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.