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A Study to Determine the Effectiveness of a Test Drug ([68Ga]BED003) for the Detection of Pancreatic, Colorectal, Gastric, Breast and Ovarian Cancer
EU CTIS ID: 2025-521983-36-00
What this study is testing
Assess the diagnostic performance of [ 68Ga]BED003 in the peritoneum.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.
- 2. Participants must be ≥ 18 years and < 80 years of age and competent to give informed consent.
- 3. Eastern Cooperative Oncology Group performance status ≤ 2.
- 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. 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. 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).
You likely can't join if
- 1. Participants administered any radioisotope within 5 physical half-lives prior to [ 68Ga]BED003 administration.
- 10. Significant renal impairment.
- 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).
- 2. Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [68Ga]BED003 administration.
- 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. Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
See the full eligibility criteria
Who can join
- 1. Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.
- 2. Participants must be ≥ 18 years and < 80 years of age and competent to give informed consent.
- 3. Eastern Cooperative Oncology Group performance status ≤ 2.
- 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. 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. 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. 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. 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.
What rules you out
- 1. Participants administered any radioisotope within 5 physical half-lives prior to [ 68Ga]BED003 administration.
- 10. Significant renal impairment.
- 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).
- 2. Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [68Ga]BED003 administration.
- 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. Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
- 5. Known hypersensitivity to [68Ga]BED003 or any of its constituents.
- 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. 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. Medical history of abdomino-pelvic or breast irradiation in the last 3 months.
- 9. Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgement.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.