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Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY94-9392 in patients with cancer or inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Cancer patients, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, PET/CT |
|
| Arm 2 | Experimental | Healthy volunteers, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY94-9392 in blood |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY94-9392 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual assessment of lesion | Day of study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative analysis of BAY94-9392 uptake into lesions (Standardized Uptake Values = SUVs) | Day of study drug administration | |
| Electrocardiogram (ECG) | At least twice within 2 days after treatment |
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Inclusion criteria:
In Germany Healthy volunteers
In Korea Patients
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford | California | 94305 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23232273 | Background | Baek S, Mueller A, Lim YS, Lee HC, Lee YJ, Gong G, Kim JS, Ryu JS, Oh SJ, Lee SJ, Bacher-Stier C, Fels L, Koglin N, Schatz CA, Dinkelborg LM, Moon DH. (4S)-4-(3-18F-fluoropropyl)-L-glutamate for imaging of xC transporter activity in hepatocellular carcinoma using PET: preclinical and exploratory clinical studies. J Nucl Med. 2013 Jan;54(1):117-23. doi: 10.2967/jnumed.112.108704. Epub 2012 Dec 11. | |
| 22893629 |
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| Blood pressure | At least twice within 2 days after treatment |
| Serum protein | At least twice within 2 days after treatment |
| Serum creatinine | At least twice within 2 days after treatment |
| Serum GOT (Glutamate-Oxalacetate-Transaminase) | At least twice within 2 days after treatment |
| Adverse events collection | Continuously for at least 4 days after treatment |
| Radiation doses per organ (µGy/MBq) | Day of study drug administration |
| Higher organ dose (HT) | Day of study drug administration |
| Doses per organ (µSv/MBq) | Day of study drug administration |
| Effective dose (µSv/MBq) | Day of study drug administration |
| Effective dose resulting from the total administered diagnostic activity of 300 MBq +/- 10% | Day of study drug administration |
| München |
| Bavaria |
| 81675 |
| Germany |
| Seoul | 138-736 | South Korea |
| Background |
| Baek S, Choi CM, Ahn SH, Lee JW, Gong G, Ryu JS, Oh SJ, Bacher-Stier C, Fels L, Koglin N, Hultsch C, Schatz CA, Dinkelborg LM, Mittra ES, Gambhir SS, Moon DH. Exploratory clinical trial of (4S)-4-(3-[18F]fluoropropyl)-L-glutamate for imaging xC- transporter using positron emission tomography in patients with non-small cell lung or breast cancer. Clin Cancer Res. 2012 Oct 1;18(19):5427-37. doi: 10.1158/1078-0432.CCR-12-0214. Epub 2012 Aug 14. |
| 23568366 | Background | Smolarz K, Krause BJ, Graner FP, Wagner FM, Hultsch C, Bacher-Stier C, Sparks RB, Ramsay S, Fels LM, Dinkelborg LM, Schwaiger M. (S)-4-(3-18F-fluoropropyl)-L-glutamic acid: an 18F-labeled tumor-specific probe for PET/CT imaging--dosimetry. J Nucl Med. 2013 Jun;54(6):861-6. doi: 10.2967/jnumed.112.112581. Epub 2013 Apr 8. |
| 32694158 | Derived | 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. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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