Diagnostic ImagingPhase 1NCT01297088
PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.
A Phase 1 study testing BAY86-9596 in people with Diagnostic Imaging, run by Lantheus Biosciences Ltd. at 2 sites in Singapore.
Trial summary
The study will be conducted as an open label, single-center, single dose and biodistribution study in patients with cancer or inflammation. 56 patients will be selected among the patients undergoing the screening examination conducted within 3 weeks before drug administration. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diagnostic Imaging
- What is being tested?
- BAY86-9596
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesSingapore
- Study dates
- May 2011to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer Patients
- Patient had an Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computer tomography(CT) performed 14 days prior to treatment with BAY86-9596 for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty, for cancers such as
- Colorectal cancer,
- Breast cancer (female patients),
- Hepatocellular carcinoma (HCC) and the cancers under colorectal cancer to hepatocellular carcinoma (HCC) are histologically confirmed (Exception, based on diagnostic criteria for the management of hepatocellular carcinoma: Histological diagnosis of hepatocelluar carcinoma is not necessary if the nodule is larger than 2 cm, has been visualized in two dynamic imaging studies and shows arterial hyperenhancement and washes out in the venous phase.)
- Patient has prostate cancer (primary or recurrent), still shows tumor mass (primary tumor and/or lymph node metastasis and/or distant metastasis) and the primary cancer disease is histologically confirmed
Show all 12Show fewer
- Patient has brain metastasis (strong evidence from imaging modalities), and the primary cancer disease is histologically confirmed.
- Patient has a primary malignant brain tumor which is either confirmed by histology, or a positive cytology of cerebrospinal fluid, or imaging modalities (such as MRI, CT) strongly support the diagnosis of brain tumor.
- Patient has some other cancer (such as ovarian cancer, melanoma), preferably with an FDG PET/CT available, and the primary cancer is histologically confirmed.
- Inflammation Patients
- Patient with inflammatory disease having inflammatory focus/foci. An FDG PET/CT of the inflammation is available.
- Patient underwent FDG PET/CT during the inflammation. The maximum interval between FDG PET/CT and examination with BAY86-9596 is 5 days, performance of both examinations on two subsequent days is recommended.
Who cannot join
- Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY86-9596, unstable and uncontrolled hypertension, severe pulmonary disease, chronic renal or hepatic disease which could compromise participation in the study. When considering hepatic function in hepatocellular cancer patients, the Child-Pugh score is applied, a score > 7 will be considered an exclusion criterion.
- Known sensitivity to the study drug or components of the preparation
- Drug abuse/dependence or history of recovered alcohol dependence.
- Patient has completed participation in another clinical study involving administration of an investigational drug in the preceding 4 weeks or is participating in any other clinical trial during this study
- Previous participation in treatment phase in this study
- Unwillingness or inability to comply with the protocol
- Patient fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety.
- Patients with inflammatory disease with known tumor where images of tumor lesions may overlap with inflammatory lesions, or tumor patients with known inflammatory diseases (e.g. autoimmune diseases), where images of inflammatory lesions may overlap with tumor lesions.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Open-label, Single Center Study of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY86-9596 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 18 µg Mass Dose) for Evaluation of Biodistribution in Pathological Tissue in Patients With Cancer or Inflammation
The study will be conducted as an open label, single-center, single dose and biodistribution study in patients with cancer or inflammation. 56 patients will be selected among the patients undergoing the screening examination conducted within 3 weeks before drug administration. Single dose of the study drug will be administrated in a dose of 300 MBq to these patients. The follow-up period contains the end-of-study telephone interview 5-8 days following the treatment. Key measurements are the PET/CT image acquisitions within a time frame of about 2 hours after the single injection of BAY86-9596.
- Conditions
- Diagnostic Imaging
- Being tested
- BAY86-9596
- Keywords
- Proof of Mechanism, Phase I, Neoplasm, Inflammation
- Medical subject headings
- Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY86-9596Drug
One single dose administration of a diagnostic agent
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY86-9596 |
What is being measured
The primary outcome is the main question the study is designed to answer.
BAY86-9596 lesion detection rate (overall number of lesions identified).
Measured: up to 2 hours
Overall image quality (poor, satisfactory, excellent; based on investigator's experience with 18F-labeled PET tracers)
Measured: up to 2 hours
BAY86-9596 accumulation score in identified lesions (low accumulation, high accumulation).
Measured: up to 2 hours
Comparative score BAY86-9596 versus FDG. If an FDG PET/CT is not available (in malignant brain tumors or in brain metastasis), this comparison will be done with routine imaging modalities such as CT or MRI, or choline PET/CT.
Measured: up to 2 hours
Comparison of BAY86-9596 accumulation with lesions identified in histology of prostate cancer.
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic ImagingStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Biosciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297088
- Sponsor's protocol ID
- 15146
- Status last verified
- Jan 2013
- First submitted
- 14 Feb 2011
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single Center Study of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY86-9596 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 18 µg Mass Dose) for Evaluation of Biodistribution in Pathological Tissue in Patients With Cancer or Inflammation
- ClinicalTrials.gov ID
- NCT01297088
- Acronym / sponsor ID
- 15146
- Conditions
- Diagnostic Imaging
- Keywords
- Proof of Mechanism, Phase I, Neoplasm, Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lantheus Biosciences Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be conducted as an open label, single-center, single dose and biodistribution study in patients with cancer or inflammation. 56 patients will be selected among the patients undergoing the screening examination conducted within 3 weeks before drug administration. Single dose of the study drug will be administrated in a dose of 300 MBq to these patients. The follow-up period contains the end-of-study telephone interview 5-8 days following the treatment. Key measurements are the PET/CT image acquisitions within a time frame of about 2 hours after the single injection of BAY86-9596.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BAY86-9596 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Cancer Patients
- Inflammation Patients
Key exclusion criteria (8 listed)
- Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY86-9596, unstable and uncontrolled hypertension, severe pulmonary disease, chronic renal or hepatic disease which could compromise participation in the study. When considering hepatic function in hepatocellular cancer patients, the Child-Pugh score is applied, a score > 7 will be considered an exclusion criterion.
- Known sensitivity to the study drug or components of the preparation
- Drug abuse/dependence or history of recovered alcohol dependence.
- Patient has completed participation in another clinical study involving administration of an investigational drug in the preceding 4 weeks or is participating in any other clinical trial during this study
- Previous participation in treatment phase in this study
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 |
|---|---|---|
| BAY86-9596One single dose administration of a diagnostic agent | Drug | Arm 1 |
Primary outcome
BAY86-9596 lesion detection rate (overall number of lesions identified).
Time frame: up to 2 hours
Overall image quality (poor, satisfactory, excellent; based on investigator's experience with 18F-labeled PET tracers)
Time frame: up to 2 hours
BAY86-9596 accumulation score in identified lesions (low accumulation, high accumulation).
Time frame: up to 2 hours
Comparative score BAY86-9596 versus FDG. If an FDG PET/CT is not available (in malignant brain tumors or in brain metastasis), this comparison will be done with routine imaging modalities such as CT or MRI, or choline PET/CT.
Time frame: up to 2 hours
Comparison of BAY86-9596 accumulation with lesions identified in histology of prostate cancer.
Time frame: up to 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2013.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY86-9596 in people with Diagnostic Imaging, run by Lantheus Biosciences Ltd. at 2 sites in Singapore.
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 12 inclusion and 8 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 21 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BAY86-9596 lesion detection rate (overall number of lesions identified). (time frame: up to 2 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2013.