A Phase 1 Study to Assess Radiation Biodistribution, Dosimetry, Pharmacokinetics and Safety of GEH300079 (68Ga) Injection and Determine the Optimal Injected Activity and Timing of PET/CT Imaging in Patients with Peritoneal Carcinomatosis of Colorectal, Gastric, Pancreatic or Ovarian Origin

2025-522541-21-00 Protocol GE-282-101 Human pharmacology (Phase I) - Other Ongoing, recruiting

Start 28 Apr 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol GE-282-101

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ongoing, recruiting
Participants planned 16
Countries 1
Sites 1

Peritoneal Carcinomatosis of Colorectal,Gastric, Pancreatic or Ovarian Origin

Key facts

Sponsor
GE Healthcare Limited
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
28 Apr 2026 → ongoing
Decision date (initial)
2026-02-24
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Peritoneal Carcinomatosis of Colorectal,Gastric, Pancreatic or Ovarian Origin

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

GE Healthcare Limited

Sponsor organisation
GE Healthcare Limited
Address
Pollards Wood, Nightingales Lane Nightingales Lane
City
Chalfont St. Giles
Postcode
HP8 4SP
Country
United Kingdom

Scientific contact point

Organisation
GE Healthcare Limited
Contact name
Aimee Liu, MD

Public contact point

Organisation
GE Healthcare Limited
Contact name
Shoma Das

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Ongoing, recruiting 16 1
Rest of world 0

Investigational sites

Sweden

1 site · Ongoing, recruiting
Karolinska University Hospital
Karolinska universitetssjukhuset i Huddinge Enheten för radiologi/ Avdelningen för nuklearmedicin, Halsovagen, Flemingsberg, Huddinge

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Sweden 2026-04-28 2026-04-28

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-12-15 Sweden Acceptable
2026-02-23
2026-02-24