Clinical Trial · NCT03697551

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

Overview

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.

Sponsor

Ipsen

Phase

Phase 2

Contacts

Ipsen Medical Director (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT03697551

Drug / Compound

OPS202

Isotope(s):

Target(s):

SSTR2

Ligand Class: Peptides

Eligibility

Inclusion

Leukocytes: ≥3x109/L, and neutrophils: ≥1x109/L
Erythrocytes: ≥3.5x1012/L
Calculated glomerular filtration rate (GFR): ≥45 mL/min
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Subjects with newly diagnosed (early or advanced) breast cancer
Platelets: ≥90x109/L
Bilirubin: ≤3xULN (3×1.1 mg/dL)
Albumin: \>30 g/L
Adequate bone marrow, liver and renal function, with:
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): ≤5 times upper limit of normal (ULN)

Exclusion

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
Subjects who are not able to tolerate the CT contrast agent
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 unable to raise arms for prolonged imaging purposes
Men with breast cancer
Subject with resected primary tumour
Clinically relevant trauma within 2 weeks prior to first 68Ga-OPS202 administration
Subjects who have received any therapy for breast cancer
Any condition that precludes the proper performance of PET and/or CT scan:
Subjects unable to lie still for the entire imaging time
Subjects weighing greater than 110 kg (243 lb)
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 with confirmed ductal carcinoma in situ
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
Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide
Subjects with metal implants or arthroplasty, or any other objects that might interfere with the PET and/or CT analysis
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
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