111Indium-labelled IPN01087 (111In-IPN01087) is developed as a radioactive diagnostic imaging agent in patients with colorectal or pancreatic cancer. It is used with single-photon emission computed tomography (SPECT) for the identification of tumours that overexpress the neurotensin receptor-1 (NTSR1). The purpose of this study is to assess how well 111In-IPN01087 is tolerated and what the most suitable amount to be injected is to obtain good quality images. The study will also look at how 111In-IPN01087 is distributed throughout the body and what the optimal time for doing the scans will be after it has been given as a single intravenous injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Administered once via slow intravenous injection.
Administered once via slow intravenous injection.
Institut Jules Bordet
Brussels, Belgium
UZ Leuven
Leuven, Belgium
Centre Léon Bérard
Léon, France
CHRU de Nancy - Hôpital de Brabois
Nancy, France
CHU de Nantes - Hôpital Hôtel Dieu
Incidence of Treatment-emergent adverse events
Safety and Tolerability
Time frame: From baseline until the end of study (12 months)
Whole body biodistribution of 111In-IPN01087 using whole body planar imaging
Time frame: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4
Maximum uptake by source region and the entire body
Time frame: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4
Time-integrated activity coefficients by source region and the entire body
Time frame: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4
Absorbed Radiation doses per organ
Time frame: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4
Specific absorbed radiation doses per organ
Time frame: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4
Organs receiving the highest radiation dose.
Time frame: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4
Normalized whole body effective dose
Time frame: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4
Total effective dose
Time frame: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4
Optimal imaging time window assessed as maximum tumour contrast on single photon emission computed tomography/computed tomography (SPECT/CT) imaging at all available timepoints post injection
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Nantes, France
Time frame: Day 1 (6 hours post-dose), Day 2, Day 3 and Day 4
Time for maximal activity in blood
Time frame: Day 1 (pre-dose, immediately after the end of the 111In-IPN01087 injection (Time 0), 30 minutes, 2 hours, 4 hours and 6 hours post-dose), Day 2, Day 3 and Day 4
Area under the time-activity curve from time 0 to the time of the last quantifiable concentration
Time frame: Day 1 (pre-dose, immediately after the end of the 111In-IPN01087 injection (Time 0), 30 minutes, 2 hours, 4 hours and 6 hours post-dose), Day 2, Day 3 and Day 4
Apparent terminal elimination half life
Time frame: Day 1 (pre-dose, immediately after the end of the 111In-IPN01087 injection (Time 0), 30 minutes, 2 hours, 4 hours and 6 hours post-dose), Day 2, Day 3 and Day 4
Cumulative amount of 111In-IPN01087 excreted in the urine over 48 hours
Time frame: From the time of the 111In-IPN01087 injection to 6 hours, from 6 hours to 24 hours and from 24 hours to 48 hours
Fraction of the administered 111In-IPN01087 excreted in urine over 48 hours
Time frame: From the time of the 111In-IPN01087 injection to 6 hours, from 6 hours to 24 hours and from 24 hours to 48 hours
Renal clearance of 111In-IPN01087
Time frame: From the time of the 111In-IPN01087 injection to 48 hours
Optimal injected radioactivity range
Time frame: Day 1 (6 hours post-dose), Day 2, Day 3 and Day 4.