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Completed

NCT Number: NCT00522951

SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study

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.

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Drug

Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw)

ProHance

Drug

ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)

Primary outcomes

  1. Number of Lesions Detected by Blinded Readers (BR) and Investigator

    Time frame: one day

    Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator

Secondary outcomes

  1. Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader

    Time frame: one day

    Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)

  2. Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator

    Time frame: one day

    Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)

  3. Score of Visibility Assessment - Border Delineation by Blinded Reader

    Time frame: one day

    Border delineation for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)

  4. Score of Visibility Assessment - Border Delineation by Investigator

    Time frame: one day

    Border delineation for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)

  5. Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)

    Time frame: one day

    Treatment planning confidence evaluated separately for each image set (gadobutrol [Gado-] 0.1 mmol/kg bw and gadoteridol [Pro-] 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)

  6. Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator

    Time frame: one day

    Treatment planning confidence evaluated separately for each image set (gadobutrol 0.1 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)

  7. Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE

    Time frame: one day

    Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)

  8. Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator

    Time frame: one day

    Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)

  9. Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE

    Time frame: one day

    Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE

  10. Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator

    Time frame: one day

    Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator

  11. Number of Participants With Reasons for Performance in SRS Planning by TPE

    Time frame: one day

    Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)

  12. Number of Participants With Reasons for Performance in SRS Planning by Investigator

    Time frame: one day

    Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)

  13. Lesion Size Evaluated by Independent Radiologist

    Time frame: one day

    Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)

  14. Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist

    Time frame: one day

    CNR of lesion/normal white matter based on the signal intensity of MR images evaluated by independent radiologist (mean and standard deviation of 306 lesions)

  15. Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions

    Time frame: one day

    ICC among 3 blinded readers calculated for number of detected lesions using the statistical model with two random effects, i.e., blinded readers and individual patients.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 30, 2007
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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