Clinical trial · Interventional
Nano MRI on 7 Tesla in Rectal and Breast Cancer
Nano MRI on 7 Tesla: a Technical Validation Study in Rectal and Breast Cancer
NCT02751606CI-TRIAL-00036040unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study evaluates the diagnostic accuracy of an USPIO contrast agent (ferumoxtran-10) in combination with 7 Tesla MRI to detect lymph node metastases in rectal and breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3 Tesla MRI | Device | — | UNRESOLVED |
| 7 Tesla MRI | Device | — | UNRESOLVED |
| ferumoxtran-10 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast and rectal cancer
- description
- Subjects will receive intravenous dose of ferumoxtran-10. 24-36 hours later a 7 Tesla MRI scan will be performed, to detect lymph node metastases. In rectal cancer patients the mesorectum will be imaged and for breast cancer patients this will be performed in the ipsilateral axilla. Subjects will also undergo a 3 Tesla MRI scan as a comparison to the 7 Tesla MRI scan.
- interventionNames
- Drug: ferumoxtran-10
- Device: 7 Tesla MRI
- Device: 3 Tesla MRI
Primary outcomes (1)
- measure
- Sensitivity and specificity of 7 Tesla MRI in combination with ferumoxtran-10 on nodal level.
- timeFrame
- within 2 weeks prior to the patients surgery
- description
- The images of the 7 Tesla MRI scan will be evaluated by a radiologist and every lymph node that is found will be scored as positive or negative. This will be compared to the pathological results to determine the sensitivity and specificity of ferumoxtran enhanced MRI on 7 Tesla for diagnosing whether a lymph node is metastatic or not.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: General criteria: * Age \> 18 years Inclusion criteria rectal cancer patients: * Patients with recently histologically proven rectal cancer, who are planned to undergo a total mesorectal excision without neo-adjuvant radiotherapy. Inclusion criteria breast cancer patients: * Patients with recently histologically proven breast cancer (Stage II), who are planned for surgery with sentinel node procedure, but will receive no neo-adjuvant therapy or will undergo an axillary lymph node dissection without prior sentinel node procedure and will receive no neo-adjuvant therapy. Exclusion Criteria: General exclusion criteria: * BMI \> 30 kg/m2 * Pregnancy * Karnofsky score \<= 70 * Contraindications for 7T MRI: * Epilepsy * Inability to provide informed consent * Metal implants that are not compatible with 7 Tesla MRI * Contraindications to USPIO based contrast agents: * prior allergic reaction to ferumoxtran-10 or any other iron preparation * prior allergic reaction contributed to dextran or other polysaccharide, in any preparation * prior allergic reaction to contrast media of any type * hereditary hemochromatosis, thalassemia, sickle cell anemia; Exclusion criteria for rectal cancer: * Inflammatory diseases of the abdomen (such as Crohn's disease) * Previous abdominal surgery or radiotherapy Exclusion criteria for breast cancer: * Prior radiotherapy or surgery to axillae
References
Publications (0)
Data not yet available
No reference posted for this study.