An exploratory, open label phase II study to evaluate the feasibility of contrast-enhanced MRI for measurement of perfusion in squamous cell cancer of the head & neck: comparison of the intravascular contrast agent Vasovist vs. the conventional contrast agent Magnevist - Vasovist in head & neck tumors

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001802-25-DE

Enrollment

Registered

2008-05-09

Start date

2008-10-27

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Patients of both gender are eligible for this study in case they present with the diagnosis of a primary squamous cell carcinoma of the head & neck after Magnevist-enhanced MRI, are scheduled for tumor biopsy or tumor surgery for clinical reasons, and meet all in- and exclusion criteria. MedDRA version: 9.1 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck

Interventions

Trade Name: Vasovist Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Gadofosveset Trisodium CAS Number: 211570-55-7 Concentration unit: mmol/ml millimole(s)/millilitre Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age: between 18 and 78 years 2. Primary squamous cell carcinoma of the epi-, oro-, hypopharynx or larynx considered for surgical resection or tumor biopsy within 21 days after Vasovist-enhanced MRI 3. Magnevist-enhanced MRI of the tumor in the head & neck region performed for clinical reasons within 3 days before the planned Vasovist-enhanced MRI 4. Willing and able to undergo all study procedures 5. Has personally provided written informed consent 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. Secondary cancer or history of cancer other than squamous cell carcinoma of the head & neck 2. Patients presenting with a contraindication to MRI such as pacemaker, aneurysm clip, or severe claustrophobia 3. History of severe allergic reaction or allergic reaction to MR contrast media 4. Patients requiring emergency treatment 5. Allergy to any of the ingredients of Vasovist 6. Patients with moderate to severe renal impairment (GFR below 60 mL/min/1.73 m2 according to MDRD or Cockcroft-Gault formula using a blood creatinine value determined within 3 days before contrast agent administration) 7. Pregnant and nursing woman (negative pregnancy test required in women of child-bearing potential – performed within 2 hours before the MR examination) 8. Having been previously enrolled in this study 9. Participating in another clinical trial

Design outcomes

Primary

Measure	Time frame
Main Objective: to assess the feasibility of perfusion measurements (permeability-surface product) with Vasovist-enhanced MR in tumors of the head and neck using immunohistochemistry of tumor tissue as the SOR;Secondary Objective: to compare further parameters of tumor perfusion (extravascular extracellular volume, blood flow, intravascular blood volume, mean transit time) with parameters of microvascular density in immunohistochemistry to compare the intravascular contrast agent Vasovist and the conventional contrast agent Magnevist with regard to their capability to assess tumor perfusion to assess the safety of Vasovist;Primary end point(s): The primary end point is the permeability-surface product as calculated from a distributed parameter analysis.	—

Measure

Time frame

Main Objective: to assess the feasibility of perfusion measurements (permeability-surface product) with Vasovist-enhanced MR in tumors of the head and neck using immunohistochemistry of tumor tissue as the SOR;Secondary Objective: to compare further parameters of tumor perfusion (extravascular extracellular volume, blood flow, intravascular blood volume, mean transit time) with parameters of microvascular density in immunohistochemistry to compare the intravascular contrast agent Vasovist and the conventional contrast agent Magnevist with regard to their capability to assess tumor perfusion to assess the safety of Vasovist;Primary end point(s): The primary end point is the permeability-surface product as calculated from a distributed parameter analysis.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Aug 9, 2026