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2014-06
2015-06
2015-06
12
NCT02162446
Ipsen
Ipsen
INTERVENTIONAL
68Ga-OPS202 Study for Diagnostic Imaging of GEP NET
The purpose of this study is to assess the safety and tolerability of 68Ga-OPS202 used for the diagnosis of gastroenteropancreatic neuroendocrine tumors (GEP NETs).
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-06-03 | 2019-07-05 | 2019-09-05 |
2014-06-10 | 2019-09-05 | 2019-10-02 |
2014-06-12 | 2019-10-02 | 2019-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 68Ga-OPS202 Satoreotide trizoxetan will be administered in two sequentially ascending peptide doses | DRUG: satoreotide trizoxetan |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs) | An AE was defined as any untoward medical occurrence in a participant administered a IP and which does not necessarily have a causal relationship with this treatment. For this study, all AEs were regarded as 'treatment emergent', i.e., not seen before administration of the IP or, if already present before administration, worsened after start of administration. An SAE was defined as an event that led to death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect. An ADR was defined as an AE with probable, possible or unlikely relationship to the administration of 68Ga-OPS202. | From start of IP administration to end of the study visit (approximately 28 to 36 days) |
| Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication | Laboratory assessments included hematology, blood biochemistry and urine analysis. Vital signs included systolic and diastolic blood pressure, heart rate and axillary body temperature. Cardiac safety was assessed by 12-lead ECGs and physical examination included general appearance, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal, neurological, endocrine, lymphatic, dermatological, psychological/psychiatric, abdomen, and genitourinary body systems. All medications (including herbal products) taken from visit 1 (Day 0) to visit 3 (7-15 days after visit 2 (3-4 weeks after visit 1), end of the study) were recorded in the participant's case report form. | From start of IP administration to end of the study visit (approximately 28 to 36 days) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Malignant and Benign Lesions Detected for Session 1 | At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over first 30 minutes; static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign by readers. Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Number of lesions for each organ/tissue and overall were calculated and absolute numbers reported. Two different read sessions were held to generate data sets for evaluation of target variables. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
| Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding | Tumor contrast in PET imaging was determined by qualitative visual analysis. 68Ga-OPS202 binding was present if at least one lesion, regardless of nature, was detected within respective tissue location. Percentages were based on number of participants with available scan at corresponding time point. | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
| Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1 | At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over the first 30 minutes (0-0.5 h); static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign lesion by the readers according to their experience. Lesion matching was performed between the somatostatin receptor scan and the 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. The mean SUVmax of lesions (mean of all identified lesions in the lymph node and liver) was summarized by nature of the lesions (malignant, benign). Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
| Mean SUVmax of Malignant and Benign Lesions for Session 2 | The mean SUVmax of all identified lesions in the respective organ/tissue was determined. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
| Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1 | Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Mean SUVmax of all selected ROIs in corresponding RT was determined. Corresponding RTs were adjacent healthy regions (1 to 3 healthy regions were identified for each lesion), i.e. located in same organ and/or region as lesion. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
| Mean SUVmax of RT for Session 2 | The mean SUVmax of all selected ROIs in the corresponding RT was determined. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
| Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1 | The tumor contrast, i.e. the SUV ratio for tumor (malignant lesion)-to-background (3D-SUV-R) of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
| The 3D-SUV-R of Malignant Lesions for Session 2 | The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected. | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
| Percent Change in 3D-SUV-R of Malignant Lesions | The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RT. For percent change, 68Ga-OPS202 receptor scan is compared to previous somatostatin receptor scan. | 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21 |
| Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location | For determining a suitable time window for PET/CT with 68Ga-OPS202, the scans after administration of the 15 μg peptide dose were analyzed and the time point with the highest lesion number per tissue location and overall were determined. If the highest number of lesion was detected at more than one time point, the earliest time point was used. | At 0.5, 1, 2, and 4 hour post-injection on Day 0 |
| Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value | The time point with the highest mean 3D-SUV-R per tissue location were determined. If the highest mean 3D-SUV-R was detected at more than one time point, the earliest time point was used. | At 0.5, 1, 2, and 4 hour post-injection on Day 0 |
| Best Diagnostic Scan Assessment | The assessment of every diagnostic 68Ga-OPS202 PET/CT scan of session 2 was rated by the reader from 1 to 5, where 1=worst diagnostic scan and 5=best diagnostic scan. Higher score indicates a better scan. | At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
