Wu Abraham J, Youssef Irini, Cohen Gil'ad N, Romesser Paul B, Taunk Neil K, Episcopia Karen, Crane Christopher H, Paty Philip, Garcia-Aguilar Julio, Weiser Martin, Smith J Joshua, Nash Garrett M, Cha Eugene, Taggar Aman, Zhang Zhigang, Damato Antonio L
Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, New York.
Adv Radiat Oncol. 2025 Apr 15;10(7):101788. doi: 10.1016/j.adro.2025.101788. eCollection 2025 Jul.
The CivaSheet is a novel radiation delivery device consisting of unidirectionally shielded Pd-103 sources embedded in a bioabsorbable polymer sheet. This facilitates intraoperative placement of permanent brachytherapy seeds in a surgical tumor bed, while minimizing dose to overlying structures. No clinical trial data have yet been published for this device. We prospectively investigated its feasibility as an alternative to standard intraoperative radiation therapy (IORT).
This was a prospective study in patients with abdomopelvic malignancies undergoing surgery with an indication for IORT. Prior external beam radiation was allowed. The primary endpoint was feasibility, defined as technically satisfactory placement of CivaSheet in ≥7 of 10 patients. Secondary endpoints were adverse events, local control, and implant stability.
Ten patients were enrolled and underwent surgery. Eight patients successfully underwent CivaSheet implantation. The 2 feasibility exclusions were technically unfavorable based on intraoperative assessment of tumor bed configuration. All implanted patients were treated to the pelvic sidewall or presacral space with a median prescription dose of 100 Gy. Median follow-up from the date of implant was 25 months. One patient had a marginal recurrence 3 months after implant, and 1 patient recurred at implant site after 13 months. One and 2-year estimates of local control were 86% and 69%, respectively. No device-related grade 4-5 adverse events were observed. Postimplant stability was deemed satisfactory in all patients.
This is the first published clinical trial of a novel unidirectional brachytherapy device. CivaSheet proved to be a feasible technique to deliver intraoperative radiation to patients with high-risk pelvic malignancies after surgical resection, and warrants further study and clinical consideration, particularly in settings where other IORT options are not available.
CivaSheet是一种新型放射治疗设备，由嵌入生物可吸收聚合物薄片中的单向屏蔽钯-103源组成。这有助于在手术肿瘤床中术中放置永久性近距离治疗种子，同时将对上覆结构的剂量降至最低。该设备尚未发表临床试验数据。我们前瞻性地研究了其作为标准术中放射治疗（IORT）替代方案的可行性。
这是一项针对有IORT指征并接受腹部盆腔恶性肿瘤手术患者的前瞻性研究。允许先前进行过外照射。主要终点是可行性，定义为在10名患者中有≥7名患者CivaSheet的放置在技术上令人满意。次要终点是不良事件、局部控制和植入稳定性。
10名患者入组并接受手术。8名患者成功进行了CivaSheet植入。根据术中对肿瘤床形态的评估，2例因技术上不可行而被排除在可行性研究之外。所有植入患者均接受盆腔侧壁或骶前间隙治疗，中位处方剂量为100 Gy。从植入日期起的中位随访时间为25个月。1例患者在植入后3个月出现边缘复发，1例患者在13个月后在植入部位复发。1年和2年局部控制率估计分别为86%和69%。未观察到与设备相关的4-5级不良事件。所有患者植入后的稳定性均被认为令人满意。
这是首次发表的关于新型单向近距离治疗设备的临床试验。CivaSheet被证明是一种可行的技术，可为手术切除后的高危盆腔恶性肿瘤患者提供术中放射治疗，值得进一步研究和临床考虑，特别是在没有其他IORT选择的情况下。
