Phase 2 Study of [68Ga]BED003 PET Imaging for Fibroblast Activation Protein Detection in Colorectal, Gastric, Pancreatic, Breast, and Ovarian Cancers
- Trial ID
- 2025-521983-36-00
- Protocol
- BED-FAP-201
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the diagnostic performance of [68Ga]BED003 in the peritoneum. This investigation targets specific oncology indications, including colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, and epithelial ovarian cancer. The secondary objectives include:
- Further assessment of the diagnostic performance of [68Ga]BED003.
- Semiquantitative assessment of tumor uptake.
- Evaluation of the safety and tolerability of the tracer.
- Confirmation of the optimal imaging timing following administration.
- Confirmation of the optimal administered activity.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of male and female patients aged between 18 and 79 years. Included individuals are diagnosed with colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, or epithelial ovarian cancer. Eligible participants must have an Eastern Cooperative Oncology Group performance status of 2 or less. The cohort includes treatment-naïve patients with at least stage IIB disease, patients who have undergone neoadjuvant therapy with scheduled biopsy or surgical resection, or those with suspected recurrence following definitive therapy. Women of childbearing potential must demonstrate negative pregnancy tests and adhere to highly-effective contraception protocols. Participants are required to have recent contrast-enhanced CT imaging of the abdomen and pelvis available for evaluation.
Plans and Procedures
This Phase 2 study is designed to assess the diagnostic performance of [68Ga]BED003 for the detection of fibroblast activation protein in the peritoneum of patients with colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, or epithelial ovarian cancer. The research methodology involves PET/CT imaging to evaluate the sensitivity and specificity of the [68Ga]BED003 injection compared to a composite standard of truth. The study sequence begins with a screening visit to confirm eligibility through histopathology or cytology, assessment of Eastern Cooperative Oncology Group performance status, and review of conventional imaging. Eligible participants proceed to a PET/CT imaging visit for intravenous administration of 240 MBq of the test substance. A safety follow-up is conducted via telephone call on Day 3. Secondary endpoints include the evaluation of standardised uptake values, tumour-to-background ratios, and adverse events. The estimated trial duration spans from April 2026 to February 2028.
Treatment
The experimental agent consists of [68Ga]BED003, which contains the active substance ga68-oncofap. This substance is prepared as a solution for injection. The administered dose is 240 MBq, delivered via an intravenous route.
Efficacy
The efficacy of [68Ga]BED003 will be evaluated through the assessment of its diagnostic performance in the peritoneum. The co-primary endpoints consist of the sensitivity and specificity of [68Ga]BED003 PET/CT in comparison to a composite standard of truth at the region level.
Secondary efficacy assessments include:
- Sensitivity, specificity, positive predictive value, and negative predictive value when compared to the composite standard of truth at both the region and participant levels.
- Standardised uptake values and tumour-to-background ratios.
- Comparison of tumour-to-background ratios and reader assessments of diagnostic quality at 30 and 60 minutes following the intravenous administration of [68Ga]BED003.
- Reader assessments of diagnostic quality utilizing simulated reduced count data.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.
- Participants must be ≥ 18 years and < 80 years of age and competent to give informed consent.
- Eastern Cooperative Oncology Group performance status ≤ 2.
- 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.
- 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).
- 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).
- 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.
- 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
- Participants administered any radioisotope within 5 physical half-lives prior to [ 68Ga]BED003 administration.
- Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [68Ga]BED003 administration.
- 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.
- Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
- Known hypersensitivity to [68Ga]BED003 or any of its constituents.
- 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.
- 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.
- Medical history of abdomino-pelvic or breast irradiation in the last 3 months.
- Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgement.
- Significant renal impairment.
- 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).
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Italy | Recruiting | 01 Apr 2026 | 38 |
 The Netherlands | Recruiting | 01 Apr 2026 | — |
| Netherlands | — | — | 27 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
[68Ga]BED003 injection | Test | SOLUTION FOR INJECTION | INTRAVENOUS | 240 | 1 | PRD12563714 |