Diagnostic ImagingPhase 1NCT01205321
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers
A Phase 1 study testing Bombesin (68Ga) labeled (BAY86-7548) in people with Diagnostic Imaging, run by Lantheus Biosciences Ltd. at 3 sites in 3 countries.
Trial summary
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-7548 in patients with cancer. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Diagnostic Imaging
- What is being tested?
- Bombesin (68Ga) labeled (BAY86-7548)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2010to 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy volunteers:
- males, >/=50 and </= 65 years of age
- Cancer patients:
- males >/= 45 years of age
- Patients had an MRI of the prostate and/or a positive choline or acetate PET/CT for diagnosis (Note: MRI, choline and acetate PET/CT are optional for primary prostate cancer patients) of recurrence prostate cancer and the primary cancer disease is/ will be histologically confirmed.
- The prostate cancer is histologically confirmed and results of histology are available.
- Patients with primary prostate cancer: >/= 20 percent of biopsy material should be affected by cancer in the histopathological evaluation.
- Patients with primary prostate cancer: Patient is scheduled to undergo prostatectomy.
Who cannot join
- Concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY86-7548, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
- Known sensitivity to the study drug or components of the preparation.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Open-label, Multi Center PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.
- Conditions
- Diagnostic Imaging
- Being tested
- Bombesin (68Ga) labeled (BAY86-7548)
- Keywords
- Neoplasm, PET/CT diagnosis, PET tracer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bombesin (68Ga) labeled (BAY86-7548)Drug
Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT
Bombesin (68Ga) labeled (BAY86-7548)Drug
Healthy volunteers, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY86-7548 in blood
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Bombesin (68Ga) labeled (BAY86-7548) |
| Arm 2 | Experimental | Not described Receives: Drug: Bombesin (68Ga) labeled (BAY86-7548) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual assessment of lesions
Measured: Day of study drug administration
Secondary outcomes (7)
Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)
Measured: Day of study drug administration
ECG (significant abnormalities)
Measured: At least 3 times until one day after treatment
Blood pressure
Measured: At least 3 times until one day after treatment
Serum protein
Measured: At least 3 times until one day after treatment
Serum creatinine
Measured: At least 3 times until one day after treatment
Serum GOT (Glutamat-Oxalacetat-Transaminase)
Measured: At least 3 times until one day after treatment
Adverse events collection
Measured: Continuously for at least 5 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionNov 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT01205321
- Sponsor's protocol ID
- 14269
- Other IDs
- 2008-008315-25, 2008
- Status last verified
- Jan 2013
- First submitted
- 17 Sep 2010
- 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, Multi Center PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01205321
- Acronym / sponsor ID
- 14269
- Conditions
- Diagnostic Imaging
- Keywords
- Neoplasm, PET/CT diagnosis, PET tracer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Lantheus Biosciences Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Sep 2010 (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.
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Bombesin (68Ga) labeled (BAY86-7548) |
| Arm 2 | Experimental | Drug: Bombesin (68Ga) labeled (BAY86-7548) |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy volunteers:
- Cancer patients:
Key exclusion criteria (2 listed)
- Concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY86-7548, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
- Known sensitivity to the study drug or components of the preparation.
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 |
|---|---|---|
| Bombesin (68Ga) labeled (BAY86-7548)Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT | Drug | Arm 1 |
| Bombesin (68Ga) labeled (BAY86-7548)Healthy volunteers, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY86-7548 in blood | Drug | Arm 2 |
Primary outcome
Visual assessment of lesions
Time frame: Day of study drug administration
7 secondary outcomes
Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)
Time frame: Day of study drug administration
ECG (significant abnormalities)
Time frame: At least 3 times until one day after treatment
Blood pressure
Time frame: At least 3 times until one day after treatment
Serum protein
Time frame: At least 3 times until one day after treatment
Serum creatinine
Time frame: At least 3 times until one day after treatment
Serum GOT (Glutamat-Oxalacetat-Transaminase)
Time frame: At least 3 times until one day after treatment
Adverse events collection
Time frame: Continuously for at least 5 days after treatment
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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bombesin (68Ga) labeled (BAY86-7548) in people with Diagnostic Imaging, run by Lantheus Biosciences Ltd. at 3 sites in 3 countries.
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 8 inclusion and 2 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 3 sites in Finland, Germany, Switzerland. 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?
Visual assessment of lesions (time frame: Day of study drug administration). 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.