A Study to Determine the Effectiveness of a Test Drug ([68Ga]BED003) for the Detection of Pancreatic, Colorectal, Gastric, Breast and Ovarian Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Blue Earth Diagnostics Ireland Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-04-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Blue Earth Diagnostics Ireland Limited

External identifiers

EU CT number

2025-521983-36-00

WHO UTN

U1111-1326-6266

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Pharmacokinetic, Safety

Assess the diagnostic performance of [ 68Ga]BED003 in the peritoneum.

Secondary objectives 5

1. 1. Further assess the diagnostic performance of [68Ga]BED003.
2. 2. Semiquantitative assessment of [68Ga]BED003 tumour uptake.
3. 3. Evaluate the safety and tolerability of [ 68Ga]BED003.
4. 4. Confirm optimal timing of imaging following [68Ga]BED003 injection (first 6 participants).
5. 5. Confirm optimal [68Ga]BED003 administered activity (first 6 participants).

Conditions and MedDRA coding

Colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.
2. 2. Participants must be ≥ 18 years and < 80 years of age and competent to give informed consent.
3. 3. Eastern Cooperative Oncology Group performance status ≤ 2.
4. 4. Women of childbearing potential (WOCBP) must have a negative serum test at screening and a negative urine pregnancy test at the PET/CT imaging visit (Visit 2) prior to [ 68Ga]BED003 administration.
5. 5. WOCBP, and men who are sexually active with WOCBP, must agree to use a highly-effective method(s) of contraception from the PET/CT imaging visit (Day 1/Visit 2) to the safety follow-up telephone call (Day 3/Visit 3).
6. 6. Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).
7. 7. Conventional imaging performed within 8 weeks of screening (Visit 1) and no later than 24 hours before [68Ga]BED003 administration and available for sending to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.
8. 8. Either (1) Treatment-naïve with at least stage IIB disease OR (2) Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42 OR (3) suspected recurrence after definitive therapy.

Exclusion criteria 11

1. 1. Participants administered any radioisotope within 5 physical half-lives prior to [ 68Ga]BED003 administration.
2. 2. Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [68Ga]BED003 administration.
3. 3. Participants who have recently received any other contrast agent (< 24 hours for IV agents and < 5 days for oral agents) before the day of [68Ga]BED003 administration.
4. 4. Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
5. 5. Known hypersensitivity to [68Ga]BED003 or any of its constituents.
6. 6. Participants with any medical condition or other circumstances at screening or in their past medical history that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or study completion.
7. 7. Known diagnosis of an autoimmune or inflammatory disorder that is expected to confound image interpretation per investigator judgement, excluding disorders directly related to the index cancer.
8. 8. Medical history of abdomino-pelvic or breast irradiation in the last 3 months.
9. 9. Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgement.
10. 10. Significant renal impairment.
11. 11. Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from the time of the [68Ga]BED003 injection the PET/CT imaging visit (Day 1/Visit 2) to the safety follow-up telephone call (Day 3/Visit 3).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Co-primary endpoints of sensitivity and specificity of [68Ga]BED003 PET/CT compared to composite standard of truth (SOT; region level: peritoneum).

Secondary endpoints 5

1. 1. Sensitivity, specificity, positive predictive value, and negative predictive value with [ 68Ga]BED003 PET/CT compared to composite SOT (region and participant level).
2. 2. Standardised uptake values and tumour-to-background ratios.
3. 3. Adverse events and serious adverse events.
4. 4. Comparison of tumour-to-background ratios and reader assessments of diagnostic quality at 30 and 60 minutes post-[ 68Ga]BED003 injection.
5. 5. Reader assessments of diagnostic quality based on simulated reduced count data.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Blue Earth Diagnostics Ireland Limited

Sponsor organisation

Blue Earth Diagnostics Ireland Limited

Address

Floor 6, 2 Grand Canal Square 2 Grand Canal Square

City

Dublin 2

Postcode

D02 A342

Country

Ireland

Scientific contact point

Organisation

Blue Earth Diagnostics Ireland Limited

Contact name

Regulatory Submissions

Public contact point

Organisation

Blue Earth Diagnostics Ireland Limited

Contact name

Regulatory Submissions

Third parties 4

Locations

2 EU/EEA countries · 6 investigational sites

By country

Investigational sites

Results and documents

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

Documents 15 files

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

Application history

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