Brain MetastasesPhase 3NCT00522951
SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
A Phase 3 study testing Gadobutrol (Gadavist, Gadovist, BAY86-4875) and ProHance in people with Brain Metastases, run by Bayer at 20 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Gadobutrol (Gadavist, Gadovist, BAY86-4875) and ProHance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 20 sitesJapan
- Study dates
- Aug 2007to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese patients at least 20 years of age
- Patients with diagnosed primary cancer
- Patients with metastatic lesions by CT/MRI
Who cannot join
- Patients who have contraindication to the MRI examinations
- Patients who have severe renal disorder
- Patients in extremely serious general condition
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Study site
Bunkyo-ku, Tokyo, 113-8431
Study site
Bunkyo-ku, Tokyo, 113-8655
Study site
Chuo-ku, Tokyo, 104-0045
Study site
Fukuoka, 812-8582
Study site
Habikino, Osaka, 583-0852
Study site
Habikino, Osaka, 583-8588
Study site
Hamamatsu, Shizuoka, 430-8558
Study site
Kitakyushu, Fukuoka, 807-8555
Study site
Kobe, Hyōgo, 650-0047
Study site
Matsuyama, Ehime, 791-0280
Study site
Mitaka, Tokyo, 181-8611
Study site
Nagoya, Aichi-ken, 464-0021
Study site
Osaka, 558-8558
Study site
Sagamihara, Kanagawa, 228-8555
Study site
Sapporo, Hokkaido, 060-8570
Study site
Sayama, Osaka, 589-8511
Study site
Shinagawa-ku, Tokyo, 141-0022
Study site
Sunto, Shizuoka, 411-8777
Study site
Yokohama, Kanagawa, 222-0036
Study site
Yonago, Tottori, 683-8504
About this study
Official 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
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
- Brain Metastases
- Being tested
- Gadobutrol (Gadavist, Gadovist, BAY86-4875), ProHance
- Keywords
- MRI, Brain Metastasis, Gadolinium, Imaging, Diagnostic Agent
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
Gadobutrol (Gadavist, Gadovist, BAY86-4875)Drug
Gadobutrol enhanced MRI (second injection of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)
ProHanceDrug
ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)
| Study group | Role | What they receive |
|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Experimental | 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 Receives: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) |
| Gadobutrol 0.2 mmol/kg bw | Experimental | 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 Receives: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) |
| Gadoteridol (ProHance) | Experimental | Participants received two injections (i.v.) of gadoteridol 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 Receives: Drug: ProHance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Lesions Detected by Blinded Readers (BR) and Investigator
Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator
Measured: one day
Secondary outcomes (15)
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader
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)
Measured: one day
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator
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)
Measured: one day
Score of Visibility Assessment - Border Delineation by Blinded Reader
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)
Measured: one day
Score of Visibility Assessment - Border Delineation by Investigator
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)
Measured: one day
Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)
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)
Measured: one day
Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator
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)
Measured: one day
Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE
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)
Measured: one day
Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator
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)
Measured: one day
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE
Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE
Measured: one day
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator
Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator
Measured: one day
Number of Participants With Reasons for Performance in SRS Planning by TPE
Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)
Measured: one day
Number of Participants With Reasons for Performance in SRS Planning by Investigator
Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)
Measured: one day
Lesion Size Evaluated by Independent Radiologist
Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)
Measured: one day
Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist
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)
Measured: one day
Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522951
- Sponsor's protocol ID
- 91569
- Other IDs
- 310864
- Status last verified
- Jul 2017
- First submitted
- 29 Aug 2007
- Last updated
- 28 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Katakami 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.
PubMed 21467949
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00522951
- Acronym / sponsor ID
- 91569
- Conditions
- Brain Metastases
- Keywords
- MRI, Brain Metastasis, Gadolinium, Imaging, Diagnostic Agent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 30 Aug 2007 (estimated)
- Results
- Posted 3 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gadobutrol 0.1 mmol/kg bw | Experimental | Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)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 |
| Gadobutrol 0.2 mmol/kg bw | Experimental | Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)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 |
| Gadoteridol (ProHance) | Experimental | Drug: ProHanceParticipants received two injections (i.v.) of gadoteridol 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Japanese patients at least 20 years of age
- Patients with diagnosed primary cancer
- Patients with metastatic lesions by CT/MRI
Key exclusion criteria (3 listed)
- Patients who have contraindication to the MRI examinations
- Patients who have severe renal disorder
- Patients in extremely serious general condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gadobutrol (Gadavist, Gadovist, BAY86-4875)Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw) | Drug | Gadobutrol 0.1 mmol/kg bw |
| Gadobutrol (Gadavist, Gadovist, BAY86-4875)Gadobutrol enhanced MRI (second injection of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw) | Drug | Gadobutrol 0.2 mmol/kg bw |
| ProHanceProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw) | Drug | Gadoteridol (ProHance) |
Primary outcome
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
15 secondary outcomes
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader
Time frame: one day
Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator
Time frame: one day
Score of Visibility Assessment - Border Delineation by Blinded Reader
Time frame: one day
Score of Visibility Assessment - Border Delineation by Investigator
Time frame: one day
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 - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator
Time frame: one day
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 - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator
Time frame: one day
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE
Time frame: one day
Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator
Time frame: one day
Number of Participants With Reasons for Performance in SRS Planning by TPE
Time frame: one day
Number of Participants With Reasons for Performance in SRS Planning by Investigator
Time frame: one day
Lesion Size Evaluated by Independent Radiologist
Time frame: one day
Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist
Time frame: one day
Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions
Time frame: one day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21467949Katakami 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gadobutrol (Gadavist, Gadovist, BAY86-4875) and ProHance in people with Brain Metastases, run by Bayer at 20 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Lesions Detected by Blinded Readers (BR) and Investigator (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00522951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.