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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

Primary Purpose

Breast Cancer

Status

Terminated

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

Satoreotide trizoxetan

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Medical University Innsbruck

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-OPS202

Arm Description

A single dose of Satoreotide trizoxetan will be administered as a slow intravenous (i.v.) bolus injected over 1 minute at Baseline/Day 1.

Outcomes

Primary Outcome Measures

Percentage of Subjects With Sufficiently Avid Lesion(s) Identified as a sstr2 Positive Lesion (Co-Primary Endpoint)

The percentage of subjects with sufficiently avid lesion(s) to be identified as a sstr2 positive lesion using 68Ga-satoreotide trizoxetan was to be determined.

Differences in the Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Between the 3 PET Acquisition Timepoints in Primary Breast Lesions (Co-Primary Endpoint)

The differences in the number of lesions detected by 68Ga-satoreotide trizoxetan between the 3 PET acquisition timepoints, and reader interpretation was to be determined.

Secondary Outcome Measures

Full Information

NCT ID

NCT03697551

First Posted

July 12, 2018

Last Updated

August 18, 2020

Sponsor

Ipsen

1. Study Identification

Unique Protocol Identification Number

NCT03697551

Brief Title

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

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Terminated

Why Stopped

Recruitment challenges and not due to safety concerns.

Study Start Date

October 22, 2018 (Actual)

Primary Completion Date

February 6, 2019 (Actual)

Study Completion Date

February 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ipsen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

68Ga-OPS202

Arm Type

Experimental

Arm Description

A single dose of Satoreotide trizoxetan will be administered as a slow intravenous (i.v.) bolus injected over 1 minute at Baseline/Day 1.

Intervention Type

Drug

Intervention Name(s)

Satoreotide trizoxetan

Other Intervention Name(s)

68Ga-OPS202, 68Ga-IPN01070

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.

Primary Outcome Measure Information:

Title

Percentage of Subjects With Sufficiently Avid Lesion(s) Identified as a sstr2 Positive Lesion (Co-Primary Endpoint)

Description

The percentage of subjects with sufficiently avid lesion(s) to be identified as a sstr2 positive lesion using 68Ga-satoreotide trizoxetan was to be determined.

Time Frame

At 0.5, 1.0 and 2.0 hours post injection on Day 1.

Title

Differences in the Number of Lesions Detected by 68Ga-Satoreotide Trizoxetan Between the 3 PET Acquisition Timepoints in Primary Breast Lesions (Co-Primary Endpoint)

Description

The differences in the number of lesions detected by 68Ga-satoreotide trizoxetan between the 3 PET acquisition timepoints, and reader interpretation was to be determined.

Time Frame

0.5, 1.0 and 2.0 hours post injection on Day 1

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ipsen Medical Director

Organizational Affiliation

Ipsen

Official's Role

Study Director

Facility Information:

Facility Name

Medical University Innsbruck

City

Innsbruck

ZIP/Postal Code

A-6020

Country

Austria

12. IPD Sharing Statement

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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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