GA68-ONCOFAP for Colorectal cancer | Gastric cancer | Pancreatic ductal adenocarcinoma | Invasive lobular breast cancer | Epithelial ovarian cancer

Inclusion criteria

• {"criterion_text":"- 1. Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.\n- 2. Participants must be ≥ 18 years and < 80 years of age and competent to give informed consent.\n- 3. Eastern Cooperative Oncology Group performance status ≤ 2.\n- 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.\n- 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).\n- 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).\n- 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.\n- 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

• {"criterion_text":"- 1. Participants administered any radioisotope within 5 physical half-lives prior to [ 68Ga]BED003 administration.\n- 10. Significant renal impairment.\n- 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).\n- 2. Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [68Ga]BED003 administration.\n- 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.\n- 4. Participants with a history of severe claustrophobia or panic attacks when in confined spaces.\n- 5. Known hypersensitivity to [68Ga]BED003 or any of its constituents.\n- 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.\n- 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.\n- 8. Medical history of abdomino-pelvic or breast irradiation in the last 3 months.\n- 9. Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgement."}

Primary endpoints

• {"endpoint_text":"- Co-primary endpoints of sensitivity and specificity of [68Ga]BED003 PET/CT compared to composite standard of truth (SOT; region level: peritoneum).","definition_or_measurement_approach":"Sensitivity and specificity of [68Ga]BED003 PET/CT measured against a composite standard of truth (SOT) at the region level (peritoneum) as comparator."}

Secondary endpoints

• {"endpoint_text":"- 1. Sensitivity, specificity, positive predictive value, and negative predictive value with [ 68Ga]BED003 PET/CT compared to composite SOT (region and participant level).\n- 2. Standardised uptake values and tumour-to-background ratios.\n- 3. Adverse events and serious adverse events.\n- 4. Comparison of tumour-to-background ratios and reader assessments of diagnostic quality at 30 and 60 minutes post-[ 68Ga]BED003 injection.\n- 5. Reader assessments of diagnostic quality based on simulated reduced count data.","definition_or_measurement_approach":"1. Diagnostic accuracy measures (sensitivity, specificity, PPV, NPV) vs composite SOT at region and participant levels. 2. Quantitative PET measures: standardized uptake values (SUVs) and tumour-to-background ratios. 3. Safety assessed by recording adverse events and serious adverse events. 4. Comparison of tumour-to-background ratios and reader diagnostic quality assessments at 30 and 60 minutes post-injection. 5. Reader diagnostic quality assessments using simulated reduced count datasets."}

Italy

Earliest CTIS Part Ii Submission Date

30-03-2026

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

31

Number Of Sites

4

Number Of Participants

38

Netherlands

Earliest CTIS Part Ii Submission Date

31-03-2026

Latest Decision Or Authorization Date

28-04-2026

Processing Time Days

28

Number Of Sites

2

Number Of Participants

27

Primary sponsor

Full Name

Blue Earth Diagnostics Ireland Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Contract research organisations

Name

Medpace Finland Oy

Responsibilities

sponsorDuties codes: 1, 12

Name

Cellcarta Naperville LLC

Responsibilities

sponsorDuties code: 4

Name

Invicro LLC

Responsibilities

sponsorDuties code: 15 (Imaging Lab)

Name

Bracco Imaging S.p.A.

Responsibilities

sponsorDuties code: 8

Third parties

• {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"sponsorDuties codes: 1, 12","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cellcarta Naperville LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Invicro LLC","duties_or_roles":"sponsorDuties code: 15 (Imaging Lab)","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Bracco Imaging S.p.A.","duties_or_roles":"sponsorDuties code: 8","organisation_type":"Pharmaceutical company"}