Define the Optimal Uptake Time of 68Ga-OPS202 When Used as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Newly Diagnosed Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03697551|
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : June 27, 2019
The purpose of this clinical research is to define the optimal uptake time of 68Ga-OPS202 as a PET imaging agent to be used to detect and localize breast cancer somatostatin receptor subtype 2 (SSTR2) positive lesions.
68Ga-OPS202 is a radiolabelled imaging agent to be used in association with PET. 68Ga-OPS202 is made of two main components: 1) OPS202, an antagonistic somatostatin analogue which binds to the somatostatin receptor (type 2) present on the surface of the tumor cells and 2) Gallium 68, a radioisotope that, combined with OPS202, can be seen in the PET scanner.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Satoreotide trizoxetan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Non-Randomised Phase II Study to Evaluate the Optimal Uptake Time of 68GA-OPS202 as a sstr2 Positive PET Imaging Agent in Subjects With Newly Diagnosed Breast Cancer|
|Actual Study Start Date :||November 8, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
A single dose of Satoreotide trizoxetan will be administered as a slow intravenous (i.v.) bolus injected over 1 minute at Baseline/Day 1.
Drug: Satoreotide trizoxetan
Subjects will receive a single dose of Satoreotide trizoxetan consisting of a peptide mass up to 45 μg, with a radioactivity range of 150-200 MBq. Satoreotide trizoxetan is intended for diagnostic use as a Positron emission tomography/computed tomography (PET/CT) tracer for the imaging of tumours expressing SSTR2.
Other Name: 68Ga-OPS202
- Percentage of subjects with sufficiently avid lesion(s) to be identified as a sstr2 positive lesion. [ Time Frame: Change from 0.5 to 1 and to 2 hours after injection on Day 1 ]Avid is defined by the blinded readers at one of the timepoints as an easily identifiable lesion radiologically, where there has been clear focal uptake of 68GA-OPS202.
- Differences in the number of lesions detected by 68Ga-OPS202 between the three PET acquisition timepoints (0.5, 1 and 2 hours) in primary breast lesions. [ Time Frame: Change from 0.5 to 1 and to 2 hours after injection on Day 1 ]
- Differences in the number of lesions detected by 68Ga-OPS202 between the three PET acquisition timepoints (0.5, 1 and 2 hours) in nodular and metastatic lesions. [ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]
- Differences at each of the three timepoints in mean standardised uptake value (SUVmean) and maximum standardised uptake value (SUVmax) [ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]As measured by the tumour-to-background ratio in the primary tumour and each of the major anatomic sites (liver, lymph nodes, bone, lungs and brain).
- Differences in relative lesion counts as a ratio of the number of lesions detected by 68Ga-OPS202 at 0.5, 1 and 2 hours post dose respectively, compared to the number of lesions assessed by standard-of-truth (descriptive analyses). [ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]The standard-of-truth is the 18F-fluorodeoxyglucose (18F-FDG) PET/CT scan images acquired at any time during the study period (including the Screening period). This will be calculated by (number of lesions detected by 68Ga-OPS202)/(number of lesions detected by 18F-FDG-PET).
- Differences of absolute number of lesions between the three PET acquisition timepoints detected in each of the following anatomic sites: - Lymph nodes - Liver - Axial/appendicular skeleton - Lungs - Brain [ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]
- Preliminary diagnostic sensitivity of 68Ga-OPS202 imaging of breast cancer expressing sstr2 positive by both subject-based and lesion-based analysis compared to standard-of-truth [ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]
- Signal-to-noise ratio (SNR) calculated from lesion-free volume of interest (VOI) in the liver: SUVmean/SUVstandard deviation at the three PET acquisition timepoints [ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]
- Estimated correlation in terms of number of avid lesions between 68Ga-OPS202 PET at the agreed "optimum timepoint" and 18F-FDG-PET [ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]
- Estimated correlation between 68Ga-OPS202 PET uptake and results of immunohistochemistry staining of sstr2 of the primary tumour. [ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]
- Proportion of subjects experiencing at least one AE of any grade according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCICTCAE) version 4.03, including any serious AEs including suspected unexpected serious adverse [ Time Frame: Up to Day 14 +/-3 (end of study) ]
- Proportion of subjects experiencing at least one AE of grade ≥3 according to NCI CTCAE. [ Time Frame: Up to Day 14 +/-3 (end of study) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697551
|Contact: Ipsen Recruitment Enquiriesemail@example.com|
|Medical University Innsbruck||Recruiting|
|Innsbruck, Austria, A-6020|
|Study Director:||Ipsen Medical Director||Ipsen|