To determine the diagnostic accuracy of MRI in detecting lymph node metastases using USPIO (Ultra small super-paramagnetic iron oxide particles) in patients with gynecological malignancy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002053-31-GB

Enrollment

100

Registered

2005-06-13

Start date

2005-08-16

Completion date

Unknown

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynaecological malignancies

Interventions

Trade Name: Sinerem Product Name: SINEREM Product Code: M00/220 Pharmaceutical Form: Powder and solvent for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults patients with gynecological malignancy 2. Patients who have provided informed cosent 3. Effective contraception, menopause or surgical sterilisation must be confrimed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients allergic to dextran or iron salts 2. Patients involved in other trials including a molecule under development 3. Female patients who are breast feeding 4. Contra-indication to MRI

Design outcomes

Primary

Measure	Time frame
Main Objective: Can we metastases in the lypmh node of patients with gynaecological malignancy using MR lymphographic contrast agent;Secondary Objective: ;Primary end point(s): To demonstrate an increased sensitivity for detection of metastatic nodes from 50%[1] on pre-contrast scans to 75% on the post contrast scan (based on sensitivities in post-contrast Phase III studies	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026