Trial Outcomes & Findings for 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 (NCT NCT03697551)

Last Updated: 2020-09-07

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

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

Results posted on

2020-09-07

Participant Flow

Female subjects with newly diagnosed breast cancer who had a somatostatin receptor subtype 2 (sstr2) positive lesion were recruited to this study from 22 October 2018, and the last subject last visit was on 6 February 2019. The study was terminated early on 9 August 2019.

Six subjects were screened and 4 subjects were eligible to receive gallium-68 (68Ga)-satoreotide trizoxetan (formerly 68Ga-OPS202) as a sstr2 positive positron emission tomography (PET) imaging agent. The screening period was up to 14 days prior to the 68Ga-satoreotide trizoxetan administration on Day 1, with a follow-up visit at Day 14.

Participant milestones

Participant milestones
Measure	68Ga-Satoreotide Trizoxetan A single dose of 68Ga-satoreotide trizoxetan was administered as a slow intravenous (iv) bolus injected over 1 minute on Day 1. The planned, per protocol single dose of 68Ga-satoreotide trizoxetan consisted of a peptide mass up to 45 micrograms, with a radioactivity range of 150-200 megabecquerel (MBq).
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	68Ga-Satoreotide Trizoxetan n=4 Participants A single dose of 68Ga-satoreotide trizoxetan was administered as a slow iv bolus injected over 1 minute on Day 1. The planned, per protocol single dose of 68Ga-satoreotide trizoxetan consisted of a peptide mass up to 45 micrograms, with a radioactivity range of 150-200 MBq.
Age, Continuous	51.8 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

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

Population: The study was stopped prematurely and only four patients were imaged, of whom only three evaluable. No summary statistics are available given the limited data from the small number of evaluable patients and individual patient data are also not presented to protect the privacy of the individuals.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 0.5, 1.0 and 2.0 hours post injection on Day 1

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.

Outcome measures

Outcome data not reported

Adverse Events

68Ga-Satoreotide Trizoxetan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Director

Ipsen

Phone: see email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place