Clinical trial NCT01186601: Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Prostatic Neoplasms
Colorectal Neoplasms
Head and Neck Neoplasms
Melanoma
Neoplasm Metastasis
Lead sponsor: Life Molecular Imaging SA
Sponsor class: INDUSTRY
First posted: 2010-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
Secondary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: Day 1
measure: Standardized uptake value ratio (SUVR)
timeFrame: Day 1
measure: Vital Signs
timeFrame: Day 1 and Day 2
measure: Laboratory Findings
timeFrame: Day 1 and Day 2
measure: Electrocardiograms (ECGs)
timeFrame: Day 1 and Day 2
measure: Adverse Event Collection
timeFrame: Day 1 and Day 2
Other outcomes:
Locations:
city: Stanford
country: United States
state: California
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Mittra 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.