Study to Evaluate the Optimal Dose of 68Ga-OPS202 as a PET Imaging Agent in Patients with GEP-NETs

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Introduction: The majority of patients diagnosed with gastroenteropancreatic (GEP)-NETs present metastases expressing somatostatin receptor 2 (SSTR2). The 68Gallium-labelled SSTR2 antagonist 68Ga-OPS202 has shown improved diagnostic performance as a PET imaging agent compared with the SSTR2 agonist 68Ga-DOTA-TOC in a single-centre study.

Aim(s): To evaluate the optimal combination of peptide mass dose and radioactivity range of a 68Ga-OPS202 kit formulation in a multicentre study.

Materials and methods: This international, phase 2, factorial-design, open-label study (NCT03220217; EudraCT: 2016-004928-39) will investigate 2 peptide mass dose ranges and 3 radioactivity ranges of a 68Ga-OPS202 kit preparation at 6 study sites. Patients with well-differentiated metastatic SSTR2-expressing GEP-NETs will be randomized to 1 of 3 study arms (n=8 per arm, 24 total completed) to attend 2 PET/CT imaging visits (2–3 week interval between visits). All patients will receive 5–20 μg of peptide mass at visit 1 and 30–45 μg at visit 2, with 1 of 3 radioactivity ranges of 68Ga (40–80, 100–140 or 160–200 MBq) per visit. Independent blinded readers at a central imaging core laboratory will evaluate the PET/CT images.

Conference: 15th Annual ENETSConcerence (2018)

Presenting Author:

Authors: Virgolini I, Brouwers A, Haug A, Grønbæk H, Kjær A,

Keywords: 68Ga-OPS202, GEP-NET, SSTR2, optimal dose range,