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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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ClinicalTrials.gov Identifier: NCT03697551
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Satoreotide trizoxetan Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 68Ga-OPS202
A single dose of Satoreotide trizoxetan will be administered as a slow intravenous (i.v.) bolus injected over 1 minute at Baseline/Day 1.
Drug: Satoreotide trizoxetan
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.
Other Name: 68Ga-OPS202




Primary Outcome Measures :
  1. 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.

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

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

  3. 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).

  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]

Other Outcome Measures:
  1. Proportion of subjects experiencing at least one AE of any grade according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCICTCAE) version 4.03, including any serious AEs including suspected unexpected serious adverse [ Time Frame: Up to Day 14 +/-3 (end of study) ]
  2. Proportion of subjects experiencing at least one AE of grade ≥3 according to NCI CTCAE. [ Time Frame: Up to Day 14 +/-3 (end of study) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697551


Contacts
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Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
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Austria
Medical University Innsbruck Recruiting
Innsbruck, Austria, A-6020
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03697551     History of Changes
Other Study ID Numbers: D-FR-01070-003
2018-000028-33 ( EudraCT Number )
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases