Clinical trial · Interventional
Tracking Peripheral Blood Mononuclear Cells With Fluorine MRI
A Phase I Study Evaluating the Feasibility of Using Fluorine-19 Cell Sense to Image Human Peripheral Blood Mononuclear Cells In Vivo
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
Cell-based therapies in the form of stem cell-based or immune cell-based therapies are becoming important treatment options that are either approved for clinical use or are showing promise in clinical trials. One of the issues regarding cell-based therapies is that, once the cells are injected into a subject, there is no easy way to track where they go, assess whether adequate numbers of cells arrive at the intended therapeutic target and for how long they persist at a given location. To address this issue non-invasive imaging methods have been developed using magnetic resonance imaging (MRI). When used with an appropriate cell labelling contrast agent, Cellular MRI can track cells non-invasively in vivo. Detection of cells is accomplished with an inert imaging agent containing the MRI sensitive fluorine-19 (19F) nuclei. The objective of this study is to demonstrate that 19F-MRI is safe to use in humans so that it can subsequently be used to track cell-based immunotherapies in future clinical trials. The long term goal is to be able to quantify immune cell migration to secondary lymphoid tissues and potentially to tumors and correlate to therapeutic outcomes.
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 |
|---|---|---|---|
| Adverse Reaction to Diagnostic Agents and Kits Nos | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 19F Cell Sense-labeled PBMC | Biological | — | UNRESOLVED |
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prostate Cancer Patients
- description
- Up to 6 Male prostate cancer patients with metastatic, castration resistant prostate cancer will be enrolled. 19F Cell Sense-labeled PBMC (3 million cells) will be injected intradermally into the upper thigh of each participant above the inguinal lymph node. MRI will be used to image the administration site.
- interventionNames
- Biological: 19F Cell Sense-labeled PBMC
- Device: MRI
- type
- EXPERIMENTAL
- label
- Healthy Volunteers
- description
- Up to 6 male or female healthy volunteers will be enrolled. 19F Cell Sense-labeled PBMC (3 million cells) will be injected intradermally into the upper thigh of each participant above the inguinal lymph node. MRI will be used to image the administration site.
- interventionNames
- Biological: 19F Cell Sense-labeled PBMC
- Device: MRI
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Men diagnosed with confirmed adenocarcinoma of the prostate * No history of skin hypersensitivities or allergies. * Normal liver functions as defined by alanine aminotransferase (ALT) (3-36 U/L) and aspirate aminotransferase (AST) levels (10-34 U/L) * Normal kidney function by monitoring urea (2.5-8.0 ηmol/L) and creatine (70-120 μmol/L \[for males\]) concentrations. * Normal complete blood count with differential * Body Weight between 40 and 110 kg (relates to being able to fit in scanner) * Body Mass Index \< 30 (relates to being able to fit in scanner) * Negative for (HIV, HTLV1\&2, Hep A, B, C, syphilis) infection as determined by approved serological testing. Exclusion Criteria: * Contraindication to venipuncture and donation of 100-160 mL of blood * Active infection (not limited to HIV, HTLV1\&2, Hep A, B, C, syphilis) * Participants are on active chemotherapy (not including castrate hormone therapy), radiation therapy or immunosuppressive therapy (i.e. steroid use, anti-transplant rejection drugs, depleting antibodies) * Participants who are unable to have an MRI scan (e.g. history of head or eye injury involving metal fragments, implanted electrical device (such as a cardiac pacemaker), conductive implants or devices such as skin patches, body piercing or tattoos containing metallic inks, severe heart disease (including susceptibility to heart rhythm abnormalities), claustrophobia, etc.) * Participants with known allergies to phenol red, β-lactams and β-lactam derivative * Participants with known allergies to streptomycin sulfate and gentamicin sulfate * Participants with unforeseen conditions that are deemed unsafe or inappropriate for the study (e.g. participants who are claustrophobic and cannot undergo an MRI) as per the discretion of the principal investigator.
References
Publications (0)
Data not yet available