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
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Satoreotide trizoxetan
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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