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New treatment option for Colorectal Cancer
Official title [68Ga]BED003 PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
ClinicalTrials.gov ID: NCT07702292
What this study is testing
What is [68Ga]BED003?
[68Ga]BED003 is an investigational medicine, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multi-centre, open-label, single-arm, Phase 2 study designed to evaluate the diagnostic performance of [68Ga]BED003 in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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. Note: If combining...
- 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...
- 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...
- Either:
- Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day 42. Cytology of the primary lesion is acceptable for participants with PDAC who are...
- Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42.
- Suspected recurrence after definitive therapy.
- 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...
- Any other primary cancers that could confound the interpretation of the study results.
- Major surgery (such as laparoscopy/laparotomy/thoracotomy) over the 3 months preceding screening that could confound the interpretation of the study results.
- Serious, non-healing wound, ulcer, or bone fracture.
- Active hepatitis.
- Significant cardiac disorders including recent (in last 3 months) myocardial infarction or clinically significant electrocardiogram (ECG) findings.
- 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 (e.g. tumour-associated...
- 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, defined as an estimated glomerular filtration rate (as determined by the Modification of Diet in Renal Disease formula) below 45 mL/min/1.73m2 or a serum creatinine \> 1.5 × the upper limit...
- Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from from the PET/CT imaging visit (Day 1/Visit 2) to the safety follow-up telephone call (Day 3/Visit...
The study team makes the final eligibility decision.
Where it's taking place
- Bergamo, Lombardy, Italy
- Monza, Lombardy, Italy
- Roma, Roma, Italy
- Milan, Segrate, Italy
- Groningen, Netherlands
- Nijmegen, Netherlands
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, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bergamo, Lombardy, Italy; Monza, Lombardy, Italy; Roma, Roma, Italy; Milan, Segrate, Italy; Groningen, Netherlands; Nijmegen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.