A non-randomised, phase II study to evaluate the optimal uptake time of 68Ga-OPS202 as a sstr2 positive PET (Positron Emission Tomography) imaging agent in subjects with newly diagnosed breast cancer.
- Conditions
- Breast CancerMedDRA version: 20.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2018-000028-33-AT
- Lead Sponsor
- Ipsen Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 54
(1) Women aged 18 years or older
(2) Subjects with newly diagnosed (early or advanced) breast cancer
(3) Eastern Cooperative Oncology Group (ECOG) performance status =2
(4) 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
(5) Signed written informed consent prior to any study-related procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 41
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13
(1) Subject with resected primary tumour
(2) Subjects with confirmed ductal carcinoma in situ
(3) Men with breast cancer
(4) 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
(5) Subjects who have received any therapy for breast cancer
(6) Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide
(7) Clinically relevant trauma within 2 weeks prior to first 68Ga-OPS202 administration
(8) 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)
(9) 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
(10) History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of systemic corticosteroids
(11) Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B or C
(12) Administration of another investigational medicinal product within 30 days prior to first
68Ga-OPS202 administration
(13) 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
(14) 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
(15) 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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method