Clinical trial · Interventional
SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
Multi-center, Randomized, Controlled, Single-blind, Intra-individual Comparisons of 2 Dose of Gadobutrol 1.0 Molar and Gadoteridol (ProHance) Crossover Studies With Corresponding Blinded Image Evaluation Following Multiple Injections of 0.1 mmol/kg bw of Gadobutrol and Gadoteridol in Patients With Known or Suspected Brain Metastasis
NCT00522951CI-TRIAL-00029298completedPhase 3Results postedClinicalTrials.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 is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.
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 |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gadobutrol (Gadavist, Gadovist, BAY86-4875) | Drug | — | UNRESOLVED |
| ProHance | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Gadobutrol 0.1 mmol/kg bw
- description
- Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
- interventionNames
- Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
- type
- EXPERIMENTAL
- label
- Gadobutrol 0.2 mmol/kg bw
- description
- Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
- interventionNames
- Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
- type
- EXPERIMENTAL
- label
- Gadoteridol (ProHance)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Japanese patients at least 20 years of age * Patients with diagnosed primary cancer * Patients with metastatic lesions by CT/MRI Exclusion Criteria: * Patients who have contraindication to the MRI examinations * Patients who have severe renal disorder * Patients in extremely serious general condition
References
Publications (1)
- RESULTKatakami N, Inaba Y, Sugata S, Tsurusaki M, Itoh T, Machida T, Tanaka H, Nakayama T, Morikawa T, Breuer J, Aitoku Y. Magnetic resonance evaluation of brain metastases from systemic malignances with two doses of gadobutrol 1.0 m compared with gadoteridol: a multicenter, phase ii/iii study in patients with known or suspected brain metastases. Invest Radiol. 2011 Jul;46(7):411-8. doi: 10.1097/RLI.0b013e3182145a6c. PMID 21467949