2025-521983-36-00招募中2 期
A Phase 2 Study of [68Ga]BED003 for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
Blue Earth Diagnostics Ireland Limited6 个研究点 分布在 2 个国家目标入组 65 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 试验地点
- 6
- 主要终点
- Co-primary endpoints of sensitivity and specificity of [68Ga]BED003 PET/CT compared to composite standard of truth (SOT; region level: peritoneum).
研究概览
简要总结
Assess the diagnostic performance of [ 68Ga]BED003 in the peritoneum.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •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.
排除标准
- •Participants administered any radioisotope within 5 physical half-lives prior to [ 68Ga]BED003 administration.
- •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).
- •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.
研究组 & 干预措施
[68Ga]BED003 injection
Test
干预措施: [68Ga]BED003 injection (Drug)
结局指标
主要结局
Co-primary endpoints of sensitivity and specificity of [68Ga]BED003 PET/CT compared to composite standard of truth (SOT; region level: peritoneum).
Co-primary endpoints of sensitivity and specificity of [68Ga]BED003 PET/CT compared to composite standard of truth (SOT; region level: peritoneum).
次要结局
- 1. Sensitivity, specificity, positive predictive value, and negative predictive value with [ 68Ga]BED003 PET/CT compared to composite SOT (region and participant level).
- 2. Standardised uptake values and tumour-to-background ratios.
- 3. Adverse events and serious adverse events.
- 4. Comparison of tumour-to-background ratios and reader assessments of diagnostic quality at 30 and 60 minutes post-[ 68Ga]BED003 injection.
- 5. Reader assessments of diagnostic quality based on simulated reduced count data.
研究者
Regulatory Submissions
Scientific
Blue Earth Diagnostics Ireland Limited
研究点 (6)
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