Gastroenteropancreatic Neuroendocrine TumorsPhase 1/2NCT02162446
68Ga-OPS202 Study for Diagnostic Imaging of GEP NET
A Phase 1/2 study testing satoreotide trizoxetan in people with Gastroenteropancreatic Neuroendocrine Tumors, run by Ipsen at 1 site in Switzerland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroenteropancreatic Neuroendocrine Tumors
- What is being tested?
- satoreotide trizoxetan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2014to Jun 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnostic CT or MRI of the tumor region within the previous 6 months prior to dosing day is available.
- A somatostatin receptor scan with results in the previous 6 months prior to dosing day.
- At least 1 lesion detected by the previous somatostatin receptor scan.
- Not exceeding 30 lesions / organ detected by the previous somatostatin receptor scan.
- Blood test results as follows (WBC: ≥ 3*109/L, Hemoglobin: ≥ 8.0 g/dL, Platelets: ≥ 50x109/L, ALT, AST, AP: ≤ 5 times ULN, Bilirubin: ≤ 3 times ULN)
- ECG: any abnormalities have to be clarified by a cardiologist.
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- Serum creatinine: within normal limits or < 120 μmol/L for patients aged 60 years or older.
- Calculated GFR ≥ 45 mL/min.
- Negative pregnancy test in women capable of child-bearing.
Who cannot join
- Known hypersensitivity to 68Ga, to NODAGA, to JR11 or to any of the excipients of 68Ga-OPS202.
- History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of corticosteroids.
- Presence of active infection at screening or history of serious infection within the previous 6 weeks.
- Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B and C.
- Any condition that precludes raised arms position for prolonged imaging purposes.
- Neuroendocrine tumor specific treatment between last somatostatin receptor imaging and start of this study. Exception is the therapeutic use of any somatostatin analog (see below).
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- Therapeutic use of any somatostatin analog, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug. If a patient is on Sandostatin® a wash-out phase of 2 days is required before the injection of the study drug.
- Administration of another investigational medicinal product within 30 days prior to entry.
- Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study.
- Current > grade 2 toxicity from previous standard or investigational therapies, per US-NCI "Common Terminology Criteria for Adverse Events v4.0".
- Pregnant or breast-feeding women.
- History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
- Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.
- Current history of malignancy; patients with a secondary tumor in remission of > 5 years can be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Micro-dosing Study to Evaluate Safety, Biodistribution, Dosimetry and Preliminary Efficacy of Two Single 68Ga-OPS202 Doses for the Diagnostic Imaging of Somatostatin Receptor-positive Gastro-entero-pancreatic Neuroendocrine Tumors (GEP NET) Using Positron-emission Tomography / Computed Tomography (PET/CT)
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).
- Being tested
- satoreotide trizoxetan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
satoreotide trizoxetanDrug
Also called 68Ga-OPS202
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-OPS202 | Experimental | Satoreotide trizoxetan will be administered in two sequentially ascending peptide doses Receives: Drug: satoreotide trizoxetan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From start of IP administration to end of the study visit (approximately 28 to 36 days)
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastroenteropancreatic Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162446
- Sponsor's protocol ID
- OPS-B-001
- Other IDs
- 2014-001881-88, 2014
- Status last verified
- Sep 2019
- First submitted
- 3 Jun 2014
- Last updated
- 2 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Micro-dosing Study to Evaluate Safety, Biodistribution, Dosimetry and Preliminary Efficacy of Two Single 68Ga-OPS202 Doses for the Diagnostic Imaging of Somatostatin Receptor-positive Gastro-entero-pancreatic Neuroendocrine Tumors (GEP NET) Using Positron-emission Tomography / Computed Tomography (PET/CT)
- ClinicalTrials.gov ID
- NCT02162446
- Acronym / sponsor ID
- OPS-B-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Posted 2 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-OPS202 | Experimental | Drug: satoreotide trizoxetanSatoreotide trizoxetan will be administered in two sequentially ascending peptide doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A diagnostic CT or MRI of the tumor region within the previous 6 months prior to dosing day is available.
- A somatostatin receptor scan with results in the previous 6 months prior to dosing day.
- At least 1 lesion detected by the previous somatostatin receptor scan.
- Not exceeding 30 lesions / organ detected by the previous somatostatin receptor scan.
- Blood test results as follows (WBC: ≥ 3*109/L, Hemoglobin: ≥ 8.0 g/dL, Platelets: ≥ 50x109/L, ALT, AST, AP: ≤ 5 times ULN, Bilirubin: ≤ 3 times ULN)
Key exclusion criteria (14 listed)
- Known hypersensitivity to 68Ga, to NODAGA, to JR11 or to any of the excipients of 68Ga-OPS202.
- History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of corticosteroids.
- Presence of active infection at screening or history of serious infection within the previous 6 weeks.
- Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B and C.
- Any condition that precludes raised arms position for prolonged imaging purposes.
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 |
|---|---|---|
| satoreotide trizoxetanAlso: 68Ga-OPS202 | Drug | 68Ga-OPS202 |
Primary outcome
Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)
Time frame: From start of IP administration to end of the study visit (approximately 28 to 36 days)
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.
Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication
Time frame: From start of IP administration to end of the study visit (approximately 28 to 36 days)
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.
12 secondary outcomes
Number of Malignant and Benign Lesions Detected for Session 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21
Mean SUVmax of RT for Session 2
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 0.5, 1, 2, and 4 hour post-injection on Day 0
Best Diagnostic Scan Assessment
Time frame: At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ipsen Medical Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing satoreotide trizoxetan in people with Gastroenteropancreatic Neuroendocrine Tumors, run by Ipsen at 1 site in Switzerland.
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 9 inclusion and 14 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 2 Oct 2019. 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 Switzerland. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs) (time frame: From start of IP administration to end of the study visit (approximately 28 to 36 days)). 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?
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 2 Oct 2019.