NeoplasmsPhase 1NCT01186601
Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer
A Phase 1 study testing PET tracer (BAY94-9392) in people with Neoplasms, run by Lantheus Biosciences Ltd. at 1 site in United States.
Trial summary
The study will be conducted as an open label, single-dose, explorative study with patients with histologically proven cancer and, preferably, tumor positive lesions in previously performed nuclear medicine imaging examinations. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- PET tracer (BAY94-9392)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Oct 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males/females >/= 18 years
- Patients with a diagnosis of primary prostate cancer (biopsy proven) and scheduled for radical prostatectomy or patients with prostate tumor recurrence (Patients with advanced tumor disease and a high likelihood to display lymph node metastasis are to be preferably included.)
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2, determined within one week prior to treatment with BAY94-9392
- Patient had an [18F]-fluorodeoxyglucose (FDG) PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty for a cancer such as melanoma, or colorectal cancer, or head \& neck cancer for which FDG-PET/CT is used in clinical routine, and the primary cancer disease is histologically confirmed. In case of recurrent disease confirmation of the primary tumor is sufficient
- No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
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 BAY94-9392, 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
- Previous treatment with BAY94-9392 in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Study for an Exploration of Tumor Accumulation of the 18F Labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to </= 0.1 mg Total Quantity) in Patients With Prostate Cancer or Other Malignant Tumors
The study will be conducted as an open label, single-dose, explorative study with patients with histologically proven cancer and, preferably, tumor positive lesions in previously performed nuclear medicine imaging examinations.
The investigational drug will be given as a single administration in a dose of </= 0.1 mg BAY94-9392 (300 MBq, +/- 10%). The total duration of the study for each patient will be approximately 8 days.
- Conditions
- Neoplasms
- Being tested
- PET tracer (BAY94-9392)
- Keywords
- Prostatic Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Melanoma, Neoplasm Metastasis
- Medical subject headings
- Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET tracer (BAY94-9392)Drug
A radioactive dose of 300 MBq of the study drug with a total quantity of </= 0.1 mg will be administered as slow intravenous bolus injection over up to 60 seconds
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: PET tracer (BAY94-9392) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology.
Measured: Day 1
Evaluation of the accumulation of BAY94-9392 in known or suspected local and/or systemic recurrent cancer lesions and/or lymph node metastasis or distant metastasis.
Measured: Day 1
Secondary outcomes (6)
Standardized uptake value (SUV)
Measured: Day 1
Standardized uptake value ratio (SUVR)
Measured: Day 1
Vital Signs
Measured: Day 1 and Day 2
Laboratory Findings
Measured: Day 1 and Day 2
Electrocardiograms (ECGs)
Measured: Day 1 and Day 2
Adverse Event Collection
Measured: Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01186601
- Sponsor's protocol ID
- 15329
- Status last verified
- Nov 2014
- First submitted
- 20 Aug 2010
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Park SY, Na SJ, Kumar M, Mosci C, Wardak M, Koglin N, Bullich S, Mueller A, Berndt M, Stephens AW, Cho YM, Ahn H, Chae SY, Kim HO, Moon DH, Gambhir SS, Mittra ES. Clinical Evaluation of (4S)-4-(3-[18F]Fluoropropyl)-L-glutamate (18F-FSPG) for PET/CT Imaging in Patients with Newly Diagnosed and Recurrent Prostate Cancer. Clin Cancer Res. 2020 Oct 15;26(20):5380-5387. doi: 10.1158/1078-0432.CCR-20-0644. Epub 2020 Jul 21.
PubMed 32694158Mittra ES, Koglin N, Mosci C, Kumar M, Hoehne A, Keu KV, Iagaru AH, Mueller A, Berndt M, Bullich S, Friebe M, Schmitt-Willich H, Gekeler V, Fels LM, Bacher-Stier C, Moon DH, Chin FT, Stephens AW, Dinkelborg LM, Gambhir SS. Pilot Preclinical and Clinical Evaluation of (4S)-4-(3-[18F]Fluoropropyl)-L-Glutamate (18F-FSPG) for PET/CT Imaging of Intracranial Malignancies. PLoS One. 2016 Feb 18;11(2):e0148628. doi: 10.1371/journal.pone.0148628. eCollection 2016.
PubMed 26890637
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study for an Exploration of Tumor Accumulation of the 18F Labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to </= 0.1 mg Total Quantity) in Patients With Prostate Cancer or Other Malignant Tumors
- ClinicalTrials.gov ID
- NCT01186601
- Acronym / sponsor ID
- 15329
- Conditions
- Neoplasms
- Keywords
- Prostatic Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Melanoma, Neoplasm Metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lantheus Biosciences Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Aug 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.
The study will be conducted as an open label, single-dose, explorative study with patients with histologically proven cancer and, preferably, tumor positive lesions in previously performed nuclear medicine imaging examinations.
The investigational drug will be given as a single administration in a dose of </= 0.1 mg BAY94-9392 (300 MBq, +/- 10%). The total duration of the study for each patient will be approximately 8 days.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: PET tracer (BAY94-9392) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males/females >/= 18 years
- Patients with a diagnosis of primary prostate cancer (biopsy proven) and scheduled for radical prostatectomy or patients with prostate tumor recurrence (Patients with advanced tumor disease and a high likelihood to display lymph node metastasis are to be preferably included.)
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2, determined within one week prior to treatment with BAY94-9392
- Patient had an [18F]-fluorodeoxyglucose (FDG) PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty for a cancer such as melanoma, or colorectal cancer, or head \& neck cancer for which FDG-PET/CT is used in clinical routine, and the primary cancer disease is histologically confirmed. In case of recurrent disease confirmation of the primary tumor is sufficient
- No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
Key exclusion criteria (3 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 BAY94-9392, 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
- Previous treatment with BAY94-9392 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 |
|---|---|---|
| PET tracer (BAY94-9392)A radioactive dose of 300 MBq of the study drug with a total quantity of </= 0.1 mg will be administered as slow intravenous bolus injection over up to 60 seconds | Drug | Arm 1 |
Primary outcome
Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology.
Time frame: Day 1
Evaluation of the accumulation of BAY94-9392 in known or suspected local and/or systemic recurrent cancer lesions and/or lymph node metastasis or distant metastasis.
Time frame: Day 1
6 secondary outcomes
Standardized uptake value (SUV)
Time frame: Day 1
Standardized uptake value ratio (SUVR)
Time frame: Day 1
Vital Signs
Time frame: Day 1 and Day 2
Laboratory Findings
Time frame: Day 1 and Day 2
Electrocardiograms (ECGs)
Time frame: Day 1 and Day 2
Adverse Event Collection
Time frame: Day 1 and Day 2
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 13 Nov 2014.
- Derived from this study: PubMed 32694158Park SY, Na SJ, Kumar M, Mosci C, Wardak M, Koglin N, Bullich S, Mueller A, Berndt M, Stephens AW, Cho YM, Ahn H, Chae SY, Kim HO, Moon DH, Gambhir SS, Mittra ES. Clinical Evaluation of (4S)-4-(3-[18F]Fluoropropyl)-L-glutamate (18F-FSPG) for PET/CT Imaging in Patients with Newly Diagnosed and Recurrent Prostate Cancer. Clin Cancer Res. 2020 Oct 15;26(20):5380-5387. doi: 10.1158/1078-0432.CCR-20-0644. Epub 2020 Jul 21.
- Derived from this study: PubMed 26890637Mittra ES, Koglin N, Mosci C, Kumar M, Hoehne A, Keu KV, Iagaru AH, Mueller A, Berndt M, Bullich S, Friebe M, Schmitt-Willich H, Gekeler V, Fels LM, Bacher-Stier C, Moon DH, Chin FT, Stephens AW, Dinkelborg LM, Gambhir SS. Pilot Preclinical and Clinical Evaluation of (4S)-4-(3-[18F]Fluoropropyl)-L-Glutamate (18F-FSPG) for PET/CT Imaging of Intracranial Malignancies. PLoS One. 2016 Feb 18;11(2):e0148628. doi: 10.1371/journal.pone.0148628. eCollection 2016.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PET tracer (BAY94-9392) in people with Neoplasms, run by Lantheus Biosciences Ltd. at 1 site in United States.
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 5 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 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology. (time frame: Day 1). The study lists 2 primary outcomes in all. 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 NCT01186601, which also lists 2 linked publications.
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 13 Nov 2014.