NCT02902107

Intraoperative Radiation Therapy for Locally Advanced or Recurrent Abdomino-pelvic Solid Tumors With the CivaSheet

Completed Phase 1 Last updated 21 October 2024

What this trial tests

Phase 1 trial testing CivaSheet in Abdominal Malignancy in 14 participants. Completed in 17 October 2024.

Timeline

9 September 2016

Primary endpoint
17 October 2024

17 October 2024

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	9 September 2016
Primary completion	17 October 2024
Estimated completion	17 October 2024
Sites	1 location across United States

Drugs / interventions tested

• CivaSheet
• Brachytherapy — full drug profile →
• surgical resection

Conditions studied

• Abdominal Malignancy — all drugs for Abdominal Malignancy →
• Pelvic Malignancy — all drugs for Pelvic Malignancy →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Abdominal Malignancy or Pelvic Malignancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a pilot study of the CivaSheet, a new type of intraoperative radiation therapy (IORT) device that offers several advantages over existing techniques of performing IORT. The CivaSheet device in this study is already approved by the FDA and is not an experimental device. This study will allow us to determine how feasible it is to implant the CivaSheet into patients undergoing surgery for abdominal and pelvic tumors, and assess any possible side effects of the device. This study, if successful, may allow us to offer the CivaSheet more widely as treatment option to future patients.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intraoperative implantation of a mesh of directional palladium sources (CivaSheet): Dosimetry verification, clinical commissioning, dose specification, and preliminary experience.
   Cohen GN, Episcopia K, Lim SB, LoSasso TJ, et al · · 2017 · cited 9× · PMID 28827006 · DOI 10.1016/j.brachy.2017.07.010
2. The CivaSheet: The new frontier of intraoperative radiation therapy or a pricier alternative to LDR brachytherapy?
   Seneviratne D, McLaughlin C, Todor D, Kaplan B, et al · · 2018 · cited 6× · PMID 29556586 · DOI 10.1016/j.adro.2017.10.005
3. Dosimetric characterization of a new directional low-dose rate brachytherapy source.
   Aima M, DeWerd LA, Mitch MG, Hammer CG, et al · · 2018 · cited 5× · PMID 29797517 · DOI 10.1002/mp.12994
4. Report of the First Patient Treated for Pelvic Sarcoma With a Directional ¹⁰³Pd Brachytherapy Device.
   Castaneda SA, Khalili M, Emrich J, Zoghbi VM, et al · · 2020 · cited 3× · PMID 32051899 · DOI 10.1016/j.adro.2019.06.007
5. Prospective Evaluation of a Novel Unidirectional Permanent Device for Intraoperative Brachytherapy.
   Wu AJ, Youssef I, Cohen GN, Romesser PB, et al · · 2025 · PMID 40524866 · DOI 10.1016/j.adro.2025.101788