Diagnostic ImagingPhase 1NCT01089998
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations
A Phase 1 study testing BAY86-9596 and Fludeoxyglucose (18F)-IBA in people with Diagnostic Imaging, run by Lantheus Biosciences Ltd. at 2 sites in 2 countries.
Trial summary
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-9596 in patients with cancer and inflammation Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Imaging
- What is being tested?
- BAY86-9596 and Fludeoxyglucose (18F)-IBA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2010to Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers only
- Males/females ≥ 50 years and ≤ 65 years of age
- Cancer patients and inflammation patients (inflammation patients in study part 2 = optional, in study part 3 mandatory)
- Males/females ≥ 30 and ≤ 80 years of age
- patients had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty, for
- NSCLC (non small cell lung cancer), or
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- adenocarcinoma of the breast (female patients) or
- squamous cell cancer of head and neck and the cancer disease is histologically confirmed.
- Patients with confirmed/known inflammatory focus/foci after FDG-PET/CT imaging
Who cannot join
- Exclusion criteria for all healthy volunteers and patients:
- any concomitant disease (for healthy volunteers) and for patients any 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 BAY86-9596, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
- For healthy volunteers and patients: known sensitivity to the study drug or components of the preparation.
- tumor patients with known inflammatory disease, where images overlap inflammatory lesions with tumor lesions
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Open-label, Multicenter Study of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY86-9596 Following a Single Intravenous Administration of 200 or 300 MBq (Corresponding to ≤ 18 µg Mass Dose) for Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers (200 MBq) as Well as Investigation of Safety, Tolerability and Diagnostic Performance in Patients (300 MBq) With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and in Patients With Inflammation.
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-9596 in patients with cancer and inflammation
- Conditions
- Diagnostic Imaging
- Being tested
- BAY86-9596, Fludeoxyglucose (18F)-IBA
- Keywords
- Neoplasm, PET/CT diagnosis, PET tracer, 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
Healthy volunteers, single intravenous bolus injection of 200 MBq BAY 86-9596 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY 86-9596 in blood and urine
BAY86-9596Drug
Cancer patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.
BAY86-9596Drug
Inflammation patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.
Fludeoxyglucose (18F)-IBADrug
Subgroup of cancer patients: radiation induced inflammation. Fluordeoxyglucose (18F)-FDG PET scan will be performed approx. 4 week after radiation and compared with tracer BAY86-9596 (acc. to Amendment 4 only in the Netherlands)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY86-9596 |
| Arm 2 | Experimental | Not described Receives: Drug: BAY86-9596 |
| Arm 3 | Experimental | Not described Receives: Drug: BAY86-9596 |
| Arm 4 | Experimental | Not described Receives: Drug: Fludeoxyglucose (18F)-IBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)
Measured: Day of study drug administration
Secondary outcomes (4)
Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs)
Measured: Day of study drug administration
Vital signs (ECG, blood pressure, Heart rate, Body temperature)
Measured: At least 2 times within 8 days after treatment
Serum chemistry, Clotting status, Hematology
Measured: At least 2 times within 8 days after treatment
Adverse Event collection
Measured: At least 2 times within 8 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 posted19 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2011
- Study completionSep 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT01089998
- Sponsor's protocol ID
- 14641
- Other IDs
- 2009-013098-16, 2009
- Status last verified
- Oct 2026
- First submitted
- 18 Mar 2010
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter Study of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY86-9596 Following a Single Intravenous Administration of 200 or 300 MBq (Corresponding to ≤ 18 µg Mass Dose) for Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers (200 MBq) as Well as Investigation of Safety, Tolerability and Diagnostic Performance in Patients (300 MBq) With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and in Patients With Inflammation.
- ClinicalTrials.gov ID
- NCT01089998
- Acronym / sponsor ID
- 14641
- Conditions
- Diagnostic Imaging
- Keywords
- Neoplasm, PET/CT diagnosis, PET tracer, Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Lantheus Biosciences Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Mar 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 BAY86-9596 in patients with cancer and inflammation
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BAY86-9596 |
| Arm 2 | Experimental | Drug: BAY86-9596 |
| Arm 3 | Experimental | Drug: BAY86-9596 |
| Arm 4 | Experimental | Drug: Fludeoxyglucose (18F)-IBA |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy volunteers only
- Cancer patients and inflammation patients (inflammation patients in study part 2 = optional, in study part 3 mandatory)
Key exclusion criteria (4 listed)
- Exclusion criteria for all healthy volunteers and patients:
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 |
|---|---|---|
| BAY86-9596Healthy volunteers, single intravenous bolus injection of 200 MBq BAY 86-9596 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY 86-9596 in blood and urine | Drug | Arm 1 |
| BAY86-9596Cancer patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT. | Drug | Arm 2 |
| BAY86-9596Inflammation patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT. | Drug | Arm 3 |
| Fludeoxyglucose (18F)-IBASubgroup of cancer patients: radiation induced inflammation. Fluordeoxyglucose (18F)-FDG PET scan will be performed approx. 4 week after radiation and compared with tracer BAY86-9596 (acc. to Amendment 4 only in the Netherlands) | Drug | Arm 4 |
Primary outcome
Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)
Time frame: Day of study drug administration
4 secondary outcomes
Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs)
Time frame: Day of study drug administration
Vital signs (ECG, blood pressure, Heart rate, Body temperature)
Time frame: At least 2 times within 8 days after treatment
Serum chemistry, Clotting status, Hematology
Time frame: At least 2 times within 8 days after treatment
Adverse Event collection
Time frame: At least 2 times within 8 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 26 Oct 2026.
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY86-9596 and Fludeoxyglucose (18F)-IBA in people with Diagnostic Imaging, run by Lantheus Biosciences Ltd. at 2 sites in 2 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 9 inclusion and 4 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 26 Oct 2026. 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 Netherlands, 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 (tumor detection rate of BAY 86-9596 compared to FDG) (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 26 Oct 2026.