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

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Tracking Information

First Submitted Date ^ICMJE

July 12, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 10, 2018

Estimated Primary Completion Date

May 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of subjects with sufficiently avid lesion(s) to be identified as a sstr2 positive lesion.[ Time Frame: Change from 0.5 to 1 and to 2 hours after injection on Day 1 ]

Avid is defined by the blinded readers at one of the timepoints as an easily identifiable lesion radiologically, where there has been clear focal uptake of 68GA-OPS202.

Differences in the number of lesions detected by 68Ga-OPS202 between the three PET acquisition timepoints (0.5, 1 and 2 hours).[ Time Frame: Change from 0.5 to 1 and to 2 hours after injection on Day 1 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Differences in the number of lesions detected by 68Ga-OPS202 between the three PET acquisition timepoints (0.5, 1 and 2 hours).[ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]
Differences at each of the three timepoints in mean standardised uptake value (SUVmean) and maximum standardised uptake value (SUVmax)[ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]
As measured by the tumour-to-background ratio in the primary tumour and each of the major anatomic sites (liver, lymph nodes, bone, lungs and brain).
Differences in relative lesion counts as a ratio of the number of lesions detected by 68Ga-OPS202 at 0.5, 1 and 2 hours post dose respectively, compared to the number of lesions assessed by standard-of-truth (descriptive analyses).[ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]
The standard-of-truth is the 18F-fluorodeoxyglucose (18F-FDG) PET/CT scan images acquired at any time during the study period (including the Screening period). This will be calculated by (number of lesions detected by 68Ga-OPS202)/(number of lesions detected by 18F-FDG-PET).
Differences of absolute number of lesions between the three PET acquisition timepoints detected in each of the following anatomic sites: - Lymph nodes - Liver - Axial/appendicular skeleton - Lungs - Brain[ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]
Preliminary diagnostic sensitivity of 68Ga-OPS202 imaging of breast cancer expressing sstr2 positive by both subject-based and lesion-based analysis compared to standard-of-truth[ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]
Signal-to-noise ratio (SNR) calculated from lesion-free volume of interest (VOI) in the liver: SUVmean/SUVstandard deviation at the three PET acquisition timepoints[ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]
Estimated correlation in terms of number of avid lesions between 68Ga-OPS202 PET at the agreed "optimum timepoint" and 18F-FDG-PET[ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]
Estimated correlation between 68Ga-OPS202 PET uptake and results of immunohistochemistry staining of sstr2 of the primary tumour.[ Time Frame: 0.5, 1 and 2 hours after injection on Day 1 ]

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Diagnostic

Condition ^ICMJE

Intervention ^ICMJE

Drug: 68Ga-OPS202
Subjects will receive a single dose of 68Ga-OPS202 consisting of a peptide mass up to 45 μg, with a radioactivity range of 150-200 MBq. 68GaOPS202 is intended for diagnostic use as a Positron emission tomography/computed tomography (PET/CT) tracer for the imaging of tumours expressing SSTR2.

Study Arms

Experimental: 68Ga-OPS202
A single dose of 68Ga-OPS202 will be administered as a slow intravenous (i.v.) bolus injected over 1 minute at Baseline/Day 1.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

May 31, 2019

Estimated Primary Completion Date

May 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Austria

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Ipsen Medical Director Ipsen

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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