Phase 2 N=12 Diagnostic

68Ga-OPS202 Study for Diagnostic Imaging of GEP NET

Gastroenteropancreatic Neuroendocrine Tumors

Bottom Line

View on ClinicalTrials.gov: NCT02162446 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs) — 6; 0; 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: satoreotide trizoxetan (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ipsen
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)	6; 0; 5	—
PRIMARY Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication	8; 7; 1; 9; 12	—
SECONDARY Number of Malignant and Benign Lesions Detected for Session 1	9.3; 17.0; 20.1; 1.0; 1.0; 1.0	0.016 sig
SECONDARY Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding	100; 100; 100; 100; 100; 16.7	—
SECONDARY Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1	4.394; 4.153; 4.455; 12.135; 10.468; 8.458	0.250
SECONDARY Mean SUVmax of Malignant and Benign Lesions for Session 2	4.938; 4.153; 4.455; 4.601; 4.564; 10.086	0.027 sig
SECONDARY Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1	0.610; 0.739; 0.636; 1.020; 0.883; 0.896	0.064
SECONDARY Mean SUVmax of RT for Session 2	0.923; 0.932; 0.976; 1.127; 2.013; 0.573	0.470
SECONDARY Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1	7.296; 6.125; 7.167; 5.227; 6.091; 5.868	0.004 sig
SECONDARY The 3D-SUV-R of Malignant Lesions for Session 2	11.191; 9.679; 5.891; 6.243; 2.169; 6.716	0.910
SECONDARY Percent Change in 3D-SUV-R of Malignant Lesions	-13.315; -0.418; 16.042; 20.052; 51.938; 50.766	—
SECONDARY Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location	5; 3; 4; 0; 2; 0	—
SECONDARY Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value	1; 0; 1; 0; 1; 0	—
SECONDARY Best Diagnostic Scan Assessment	4.0; 5.0; 5.0; 4.5; 2.0	—

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).

Eligibility Criteria

Inclusion Criteria

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.
Serum creatinine: within normal limits or 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02162446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.