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

NCT03697551 | Terminated Phase 2 Results

• 2 other identifiers: D-FR-01070-0032018-000028-33
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

68Ga-OPS202

EXPERIMENTAL

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

Interventions

Satoreotide trizoxetan DRUG

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.

Also known as: 68Ga-OPS202, 68Ga-IPN01070

68Ga-OPS202

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, A-6020, Austria

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The study was terminated early on 9 August 2019 due to recruitment challenges and the potential overlap with another Ipsen study, and not due to safety concerns.

Results Point of Contact

• Title: Medical Director
• Organization: Ipsen

clinical.trials@ipsen.com

see email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: October 5, 2018
• Study Start: October 22, 2018
• Primary Completion: February 6, 2019
• Study Completion: February 6, 2019
• Last Updated: September 7, 2020
• Results First Posted: September 7, 2020

Record last verified: 2020-08

Locations

AU (1)