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

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Satoreotide trizoxetan

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, A-6020
    • Medical University Innsbruck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women aged 18 years or older
• Subjects with newly diagnosed (early or advanced) breast cancer
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2

• Adequate bone marrow, liver and renal function, with:

  • Calculated glomerular filtration rate (GFR): ≥45 mL/min
  • Albumin: >30 g/L
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): ≤5 times upper limit of normal (ULN)
  • Bilirubin: ≤3xULN (3×1.1 mg/dL)
  • Leukocytes: ≥3x109/L, and neutrophils: ≥1x109/L
  • Erythrocytes: ≥3.5x1012/L
  • Platelets: ≥90x109/L
• Signed written informed consent prior to any study-related procedures.

Exclusion Criteria:

• Subject with resected primary tumour
• Subjects with confirmed ductal carcinoma in situ
• Men with breast cancer
• Presence of an active infection at screening or history of a serious infection within the previous 6 weeks prior to the first 68Ga-OPS202 administration that might interfere with the PET and/or CT analysis
• Subjects who have received any therapy for breast cancer
• Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide
• Clinically relevant trauma within 2 weeks prior to first 68Ga-OPS202 administration

• Any condition that precludes the proper performance of PET and/or CT scan:

  • Subjects who are not able to tolerate the CT contrast agent
  • Subjects with metal implants or arthroplasty, or any other objects that might interfere with the PET and/or CT analysis
  • Subjects unable to raise arms for prolonged imaging purposes
  • Subjects unable to lie still for the entire imaging time
  • Subjects weighing greater than 110 kg (243 lb)
• Known hypersensitivity to radiolabelled NODAGA (1,4,7- triazacyclononane,1-glutaric acid 4,7 acetic acid), to Gallium-68, to somatostatin analogue peptide 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 systemic corticosteroids
• Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B or C
• Administration of another investigational medicinal product within 30 days prior to first 68Ga-OPS202 administration
• Subjects who are pregnant, breast feeding or of childbearing potential not willing to practice effective contraceptive techniques during the study treatment period and for 30 days after the last dose of 68Ga-OPS202 administration; pregnancy test must be performed at the start of the study and prior to 68Ga-OPS202 administration
• Subjects who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including any mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude
• Subject who experienced a previous cancer (except basocellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus), and/or subjects treated with curative intent and free from disease for more than 5 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 68Ga-OPS202; 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 Names: 68Ga-OPS202; 68Ga-IPN01070

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Sufficiently Avid Lesion(s) Identified as a sstr2 Positive Lesion (Co-Primary Endpoint)	The percentage of subjects with sufficiently avid lesion(s) to be identified as a sstr2 positive lesion using 68Ga-satoreotide trizoxetan was to be determined.	At 0.5, 1.0 and 2.0 hours post injection on Day 1.
Differences in the Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Between the 3 PET Acquisition Timepoints in Primary Breast Lesions (Co-Primary Endpoint)	The differences in the number of lesions detected by 68Ga-satoreotide trizoxetan between the 3 PET acquisition timepoints, and reader interpretation was to be determined.	0.5, 1.0 and 2.0 hours post injection on Day 1

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 22, 2018
• Primary Completion (ACTUAL): February 6, 2019
• Study Completion (ACTUAL): February 6, 2019

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (ACTUAL): October 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: D-FR-01070-003; 2018-000028-33 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No