Clinical trial · Interventional
Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide
A Pilot Study of MR Imaging With Ultra-small Superparamagnetic Iron Oxide for Pelvic Lymph Node Target Definition
- 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)
The purpose of this study is to test whether or not a new contrast agent called Combidex, a contrast agent formulated from ultra-small superparamagnetic iron oxide (USPIO) improves the ability of Magnetic Resonance Imaging (MRI) to see lymph nodes in the pelvis. It might also help doctors tell whether or not cancer has spread to these lymph nodes. It might allow radiotherapy to be delivered more accurately.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Neoplasms | Bladder Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Cervix Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| Uterine Neoplasms | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI contrast agent Combidex (ferumoxtran-10) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers.
- timeFrame
- once at time of imaging
- measure
- Improved clinical target volume (CTV) definition for the purpose of adjuvant irradiation of pelvic lymph nodes using intensity modulated radiotherapy (IMRT).
- timeFrame
- once at time of imaging
Secondary outcomes (2)
- measure
- Comparison of target lymph node delineation between nodal imaging with USPIO and volume expansion of vascular anatomy.
- timeFrame
- once at time of imaging
- measure
- Demonstration of the pattern and distribution of pelvic nodal metastases in patients with uterine, cervical, bladder and prostate cancers.
- timeFrame
- once at time of imaging
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed endometrial, cervix, prostate (cT1-cT3) or bladder cancer * no distant metastases * informed consent Exclusion Criteria: * confirmed prostate carcinoma and PSA less than or equal to 4 or greater than 100 * radical surgery or prior cryosurgery for prostate carcinoma, previous RT, hormonal manipulation or chemotherapy * biopsy-proven lymph node involvement * endometrium or cervix carcinoma who have undergone recent pelvic surgery with the exclusion of D\&C or biopsy * bladder carcinoma with recent pelvic surgery with the exclusion of TURBT * previous or concurrent cancers other than superficial basal or squamous cell skin carcinoma unless disease-free for at least 5 yrs * contraindication to MR imaging * hip prosthesis * major medical or psychiatric illness * patients with known allergy to dextran or iron-containing compounds * patients with cirrhosis or hemochromatosis * patients receiving another MR contrast within 2 hrs prior to the ferumoxtran-10
References
Publications (0)
Data not yet available