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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-10-05
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Percentage of Subjects With Sufficiently Avid Lesion(s) Identified as a sstr2 Positive Lesion (Co-Primary Endpoint)
timeFrame: At 0.5, 1.0 and 2.0 hours post injection on Day 1.
measure: Differences in the Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Between the 3 PET Acquisition Timepoints in Primary Breast Lesions (Co-Primary Endpoint)
timeFrame: 0.5, 1.0 and 2.0 hours post injection on Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: