Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients with Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GE Healthcare Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

29 Apr 2026 → ongoing

Decision date (initial)

2026-06-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

GE HealthCare Ltd.

External identifiers

EU CT number

2024-519384-18-00

ClinicalTrials.gov

NCT07219238

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Evaluate the diagnostic performance of GEH300079 (68Ga) PET/CT imaging for the detection of PC in patients with colorectal, gastric or ovarian primary cancers

Secondary objectives 1

1. Compare the diagnostic performance of GEH300079 (68Ga) PET/CT for the detection of PC with baseline standard of care (SoC) imaging (i.e., CT, magnetic resonance [MR], and/or [18F]fluorodeoxyglucose [FDG] PET) in patients with colorectal, gastric or ovarian primary cancers

Conditions and MedDRA coding

Colorectal, Gastric, Ovarian or Pancreatic Cancer

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Participant is ≥18 years of age
2. Participant has provided signed informed consent before any study-specific screening procedures
3. Participant has histopathologically confirmed primary colorectal, gastric or ovarian cancer or PDAC
4. Participant has known or suspected PC from the tumor of origin. Suspicion may be based on imaging or clinical findings
5. Participant is scheduled for peritoneal surgery with curative intent, surgical exploration, or laparoscopy, with either: a. No neoadjuvant treatment received, treatment-naïve (i.e., undergoing upfront surgery or laparoscopy) b. Completed systemic treatment (which may include neoadjuvant chemotherapy) before GEH300079 (68Ga) PET/CT Imaging Visit
6. Participant has Eastern Cooperative Oncology Group (ECOG) performance status ≤2
7. Participant is able and willing to comply with all study procedures as described in the protocol

Exclusion criteria 14

1. Participant is pregnant or breast-feeding, or sexually active and not using or not willing to use an acceptable form of birth control from at least 30 days before the screening visit until 30 days after receiving the investigational medicinal product (IMP)
2. Participant has a known disorder that, in the opinion of the investigator, will impact the study procedures
3. Participant needs any intervention that would delay study participation
4. Participant has non-resectable extra-abdominal metastasis and/or >3 hepatic metastases on standard workup
5. Participant will not be able to complete the study, based on their anticipated life expectancy
6. Participant has active bacterial, viral, or fungal infection requiring systemic antibacterial, anti-viral or antifungal therapy (topical medications are permitted)
7. Participant has renal function impairment as defined by: a. For Phase 2: estimated glomerular filtration rate less than 60 mL/min b. For Phase 3: estimated glomerular filtration rate less than 30 mL/min
8. Participant has severe hepatic function impairment as defined by either: a. Aspartate aminotransferase or alanine aminotransferase: >5 × upper limit of normal (ULN); or b. Total bilirubin >3 × ULN
9. Participant has Crohn’s disease, ulcerative colitis, or sarcoidosis
10. Participant has serious co-morbidities or serious non-malignant disease that in the opinion of the investigator, could compromise participant safety and/or protocol objectives
11. Participant either received or is planning to receive any other investigational agent within the 28 days prior to the first imaging visit or during study participation (with the exception of the 3-month follow-up period)
12. Participant has known or suspected hypersensitivity to any excipients used in GEH300079 (68Ga)
13. Participant has severe claustrophobia, is unable to lie flat or fit into the scanner, or is unable to tolerate the PET/CT scan for any reason
14. (Phase 3 only) Participant was previously included in Phase 2 of this study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 13

1. Phase 2 Efficacy Endpoints: Co-Primary Endpoints: • Per-region sensitivity of GEH300079 (68Ga) PET/CT imaging to detect PC, superior to a pre-specified threshold of 75% and • Per-region specificity of GEH300079 (68Ga) PET/CT imaging to detect PC, superior to a pre-specified threshold of 70%
2. Phase 2 Exploratory Endpoints: • SUVmean and SUVmax thresholds that best discriminate Positive and Negative PC lesions • Detection of primary lesions per participant by GEH300079 (68Ga) PET/CT as compared to baseline SoC imaging, based on on-site read
3. Phase 2 Exploratory Endpoints: • Number of organs/anatomic structures with potential extra-PC metastases (including involvement in viscera, bones, lymph nodes) identified on GEH300079 (68Ga) PET/CT and baseline SoC imaging per participant, and percentage of participants with at least 1 organ/anatomic structure with potential extra-PC metastases identified by GEH300079 (68Ga) PET/CT scan as compared to baseline SoC imaging, based on on-site read
4. Phase 2 Safety Endpoints: Adverse events: • Incidence of treatment-emergent AEs (TEAEs) by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term (PT) Urinalysis and clinical laboratory parameters: • Observed values and changes from baseline • Occurrence of changes from baseline values of >40% and >80% of the span of the normal limits • Occurrence of post-administration values outside the normal limits
5. Phase 2 Safety Endpoints: Vital signs (BP, RR, HR, body temperature): • Observed values and changes from baseline • Occurrence of changes from baseline greater than a pre-specified magnitude (20 mmHg for systolic BP, 10 mmHg for diastolic BP, 10 beats per minute for HR, 10 breaths per minute for RR, 1.5°C for body temperature) • Occurrence of post-administration values outside the normal limits
6. Phase 2 Safety Endpoints: Electrocardiography: • Observed values and changes from baseline • Occurrence of changes from baseline within the following pre-specified increments: • Increments of 4 ms (<4, ≥4 to ≤8, >8 to ≤12, and >12 ms), 10 ms (<10, ≥10 to ≤20, and >20 ms) and 25 ms (<25, ≥25 to ≤50, and >50 ms) for PR interval • <30 ms, ≥30 to ≤60 ms, and >60 ms increments for QTcF interval
7. Phase 2 Safety Endpoints: Electrocardiography: • <50 ms, ≥50 to ≤100 ms, and >100 ms increments for QRS interval • <250 ms, ≥250 to ≤500 ms, and >500 ms increments for RR interval • Occurrence of post-administration values outside the normal limits in the PR, QTc, QRS or RR interval • Overall interpretation at each post-administration time point Physical examination: • Occurrence of changes from baseline in physical examination status (normal/abnormal)
8. Phase 3: Efficacy Endpoints: • Per-region sensitivity of GEH300079 (68Ga) PET/CT imaging for the detection of PC, superior to a prespecified threshold of 75% and • Per-region specificity of GEH300079 (68Ga) PET/CT imaging for the detection of PC, superior to a prespecified threshold of 70%
9. Phase 3: Exploratory Endpoints: • SUVmean and SUVmax thresholds that best discriminate Positive and Negative PC lesions • Detection of primary lesions per participant by GEH300079 (68Ga) PET/CT as compared to baseline SoC imaging, based on on-site read
10. Phase 3: Exploratory Endpoints: • Number of organs/anatomic structures with potential extra-PC metastases (including involvement in viscera, bones, lymph nodes) identified on GEH300079 (68Ga) PET/CT and baseline SoC imaging per participant, and percentage of participants with at least 1 organ/anatomic structure with potential extra-PC metastases identified by GEH300079 (68Ga) PET/CT scan as compared to baseline SoC imaging, based on on-site read
11. Phase 3: Safety Endpoints: AEs: • Incidence of TEAEs by MedDRA system organ class and PT Urinalysis and clinical laboratory parameters: • Observed values and changes from baseline • Occurrence of changes from baseline values of >40% and >80% of the span of the normal limits • Occurrence of post-administration values outside the normal limits
12. Phase 3: Safety Endpoints: Vital signs (BP, RR, HR, body temperature): • Observed values and changes from baseline • Occurrence of changes from baseline greater than a pre-specified magnitude (20 mmHg for systolic BP, 10 mmHg for diastolic BP, 10 beats per minute for HR, 10 breaths per minute for RR, 1.5°C for body temperature)
13. Phase 3: Safety Endpoints: Vital signs (BP, RR, HR, body temperature): • Occurrence of post-administration values outside the normal limits Physical examination: • Occurrence of changes from baseline in physical examination status (normal/abnormal)

Secondary endpoints 2

1. Phase 2: Efficacy Endpoints: Co-key Secondary Endpoints: I. Superiority of the per region sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging (i.e., CT, MR, or [18F]FDG PET/CT) and II. Non-inferiority of the per region specificity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging
2. Phase 3: Efficacy Endpoints: Co-Key Secondary Endpoints: I. Superiority of the per region sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging (i.e., CT, MR or [18F]FDG PET/CT) and II. Non-inferiority of the per region specificity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

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

GE Healthcare

Third parties 3

Locations

2 EU/EEA countries · 2 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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