Towards Improved Therapy Selection and Targeted Treatment for Nasopharyngeal Carcinoma: a Proof-of-concept Pilot Study for Somatostatin Receptor 2 Imaging With [68Ga]Ga-DOTA-TOC PET/CT.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility of assessing tumor SSTR2 expression
研究概览
简要总结
This is an investigator-initiated, single-center clinical trial designed to evaluate the feasibility of [68Ga]Ga-DOTA-TOC positron emission tomography (PET) scan in patients with Epstein-Barr virus (EBV) related nasopharyngeal carcinome (NPC) prior to and three weeks after the start of induction chemotherapy or concurrent chemoradiotherapy (CRT). Archival tumor tissue from the diagnostic biopsy will be used to perform somatostatin receptor 2 (SSTR2) immunohistochemistry (IHC). Blood samples will be drawn at baseline, after three weeks, after completion of induction chemotherapy if applicable, and after CRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage IB-IVA NPC (AJCC 9th edition), EBV positive determined by Epstein-Barr virus-encoded RNA (EBER).
- •Planned treatment with induction chemotherapy or CRT without induction chemotherapy.
- •Age ≥ 18 years.
- •Signed informed consent.
- •Willingness and ability to comply with all protocol required procedures.
- •Negative serum pregnancy test at screening in women of childbearing potential.
- •Archival tumor tissue available or consent to undergo a tumor biopsy procedure.
排除标准
- •Previous treatment with chemotherapy or radiotherapy for NPC.
- •Treatment with any investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to [68Ga]Ga-DOTA-TOC injection.
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or that may affect the interpretation of the results or render the patient at high risk from complications.
- •Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- •Inability to lie in supine position for 25 minutes.
- •Patients who are pregnant or breastfeeding.
研究组 & 干预措施
[68Ga]Ga-DOTA-TOC PET imaging
干预措施: [68Ga]Ga-DOTA-TOC PET imaging (Other)
结局指标
主要结局
Feasibility of assessing tumor SSTR2 expression
时间窗: From the day of the first study scan within one week before the start of treatment to the day of the second study scan three weeks after the start of treatment
Determine feasibility of assessing tumor SSTR2 expression in patients with EBV-associated NPC in a non-endemic region by repeat \[68Ga\]Ga-DOTA-TOC PET imaging.
次要结局
- [68Ga]Ga-DOTA-TOC uptake in the primary tumor and lymph node metastase(From the day of the first study scan within one week before the start of treatment to the day of the second study scan three weeks after the start of treatment)
- Comparison [68Ga]Ga-DOTA-TOC uptake with SSTR expression(The day of the first study scan within one week before the start of treatment)
- [68Ga]Ga-DOTA-TOC distribution(From the day of the first study scan within one week before the start of treatment to the day of the second study scan three weeks after the start of treatment)