Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL - Diffuse Large B Cell Lymphoma | Interdigitating Dendritic Cell Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI contrast-enhancing agents | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intravenous injection of ferumoxytol as off-label MRI contrast agent for tracking of macrophages
- description
- ImmunoMRI for tracking of TAMs will be integrated into 18F-FDG-PET/MRI scans that are performed for routine clinical purposes -i.e., assessment of disease extent before, and response assessment after/on treatment- to minimize patient discomfort and improve compliance. ImmunoMRI will be based on an iron sensitive fat-suppressed, fast spoiled gradient echo T2\* mapping sequence, obtained before and after intravenous injection of the iron oxide nanoparticle ferumoxytol (commerical name: Feraheme). For each patient immunoMRI will be performed twice: before treatment, and 3-4 weeks after start of treatment (CAR T cells or bispecific antibodies).
- interventionNames
- Drug: MRI contrast-enhancing agents
Primary outcomes (5)
- measure
- Correlation between immunoMRI and M1 and M2 TAM-directed IHC
- timeFrame
- Through study completion, 3 years
- description
- To determine the associations between pre-treatment immunoMRI metrics and IHC-based TAM levels, median/mean T2\* will be calculated for each of the four IHC categories (score 1-4), separately for M1 and M2 TAMs, and Spearman rank correlation coefficients will be calculated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathology-proven relapsed/refractory DLBCL 2. 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. 3. Ability to understand the study goals or outline and to give written informed consent. Exclusion Criteria: 1. 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. 2. Age below the specified minimum of 18 years. 3. Any type of anemia at baseline (due to potentially altered ferumoxytol uptake) 4. Impaired renal function / renal insufficiency 5. Known contraindication to MRI (per MRI Safety Guidelines, or conditions such as claustrophobia) 6. Known hypersensitivity to ferumoxytol or any of its components, or history of allergic reaction to any intravenous iron product.
References
Publications (5)
- BACKGROUNDNeelapu SS, Tummala S, Kebriaei P, Wierda W, Gutierrez C, Locke FL, Komanduri KV, Lin Y, Jain N, Daver N, Westin J, Gulbis AM, Loghin ME, de Groot JF, Adkins S, Davis SE, Rezvani K, Hwu P, Shpall EJ. Chimeric antigen receptor T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol. 2018 Jan;15(1):47-62. doi: 10.1038/nrclinonc.2017.148. Epub 2017 Sep 19. PMID 28925994
- BACKGROUNDKamdar M, Solomon SR, Arnason J, Johnston PB, Glass B, Bachanova V, Ibrahimi S, Mielke S, Mutsaers P, Hernandez-Ilizaliturri F, Izutsu K, Morschhauser F, Lunning M, Maloney DG, Crotta A, Montheard S, Previtali A, Stepan L, Ogasawara K, Mack T, Abramson JS; TRANSFORM Investigators. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial. Lancet. 2022 Jun 18;399(10343):2294-2308. doi: 10.1016/S0140-6736(22)00662-6. PMID 35717989
- BACKGROUNDKochenderfer JN, Dudley ME, Kassim SH, Somerville RP, Carpenter RO, Stetler-Stevenson M, Yang JC, Phan GQ, Hughes MS, Sherry RM, Raffeld M, Feldman S, Lu L, Li YF, Ngo LT, Goy A, Feldman T, Spaner DE, Wang ML, Chen CC, Kranick SM, Nath A, Nathan DA, Morton KE, Toomey MA, Rosenberg SA. Chemotherapy-refractory diffuse large B-cell lymphoma and indolent B-cell malignancies can be effectively treated with autologous T cells expressing an anti-CD19 chimeric antigen receptor. J Clin Oncol. 2015 Feb 20;33(6):540-9. doi: 10.1200/JCO.2014.56.2025. Epub 2014 Aug 25. PMID 25154820
- BACKGROUNDNguyen KL, Yoshida T, Kathuria-Prakash N, Zaki IH, Varallyay CG, Semple SI, Saouaf R, Rigsby CK, Stoumpos S, Whitehead KK, Griffin LM, Saloner D, Hope MD, Prince MR, Fogel MA, Schiebler ML, Roditi GH, Radjenovic A, Newby DE, Neuwelt EA, Bashir MR, Hu P, Finn JP. Multicenter Safety and Practice for Off-Label Diagnostic Use of Ferumoxytol in MRI. Radiology. 2019 Dec;293(3):554-564. doi: 10.1148/radiol.2019190477. Epub 2019 Oct 22. PMID 31638489
- Aghighi M, Theruvath AJ, Pareek A, Pisani LL, Alford R, Muehe AM, Sethi TK, Holdsworth SJ, Hazard FK, Gratzinger D, Luna-Fineman S, Advani R, Spunt SL, Daldrup-Link HE. Magnetic Resonance Imaging of Tumor-Associated Macrophages: Clinical Translation. Clin Cancer Res. 2018 Sep 1;24(17):4110-4118. doi: 10.1158/1078-0432.CCR-18-0673. Epub 2018 May 15.