Clinical trial • Phase I • Oncology

Gallium-68 (68Ga) for Peritoneal carcinomatosis (colorectal origin) | Peritoneal carcinomatosis (gastric origin) | Peritoneal carcinomatosis (pancreatic origin) | Peritoneal carcinomatosis (ovarian origin)

Phase I trial of Gallium-68 (68Ga) for Peritoneal carcinomatosis (colorectal origin) | Peritoneal carcinomatosis (gastric origin) | Peritoneal carcinomato…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Peritoneal carcinomatosis (colorectal origin) | Peritoneal carcinomatosis (gastric origin) | Peritoneal carcinomatosis (pancreatic origin) | Peritoneal carcinomatosis (ovarian origin)
Trial Stage
Phase I
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
15-12-2025
First CTIS Authorization Date
24-02-2026

Trial design

None/Not specified-controlled Phase I trial across 1 site in Sweden.

Comparator
None/Not specified
Target Sample Size
16

Recruitment

Planned Sample Size
16
Recruitment Window Months
20

Geography

Total Number Of Sites
1
Total Number Of Participants
16

Sweden

Earliest CTIS Part Ii Submission Date
13-02-2026
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
11
Number Of Sites
1
Number Of Participants
16

Sites

Site Name
Karolinska University Hospital
Department Name
Karolinska universitetssjukhuset i Huddinge Enheten för radiologi/ Avdelningen för nuklearmedicin
Contact Person Name
Pawel Rasinski

Sponsor

Primary sponsor

Full Name
GE Healthcare Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Investigational products

Investigational Product Name
GEH300079 (68Ga) Injection
Active Substance
Gallium-68 (68Ga)
Modality
Radiopharmaceutical
Routes Of Administration
Injection
Route
Injection
Authorisation Status
Investigational

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