CivaSheet® use for soft tissue sarcoma: A single institution experience.

OBJECTIVE: CivaSheet is a palladium-103, implantable, intraoperative radiation therapy device which emits unidirectional radiation that enables boost doses in patients who have otherwise received the maximum radiation dose. Here, we present our initial clinical experience with the first 10 cases using this new technology. METHODS AND MATERIALS: A retrospective chart review of all patients with STS treated with surgical resection and CivaSheet placement at the University of Miami Hospital, a tertiary care center, from January 2018 to December 2019, was performed. Adjuvant radiation was administered by a palladium-103 implant, which delivered an average of 47 Gy (35-55) to a depth of 5 mm. RESULTS: Nine patients underwent CivaSheet placement from January 2018 until December 2019 for a total of 10 CivaSheets placed (1 patient had 2 CivaSheets inserted) and followed for a mean of 27 months (4-45 months). Four tumors were located in the retroperitoneum, two in the chest, two in the groin, and two within the lower extremity. At the time of tumor resection and CivaSheet placement, tumor sizes ranged from 2.5 cm to 13.8 cm with an average of 7.6 cm. Four patients necessitated musculocutaneous tissue flaps for closure and reconstruction. All patients with Grade 4 complications had flap reconstruction and prior radiation. Four patients' tumors recurred locally for a local recurrence rate of 40%. Three patients had modified accordion Grade 4 complications necessitating additional surgery for CivaSheet removal. Extremity tumors unanimously developed modified accordion Grade 4 adverse events. CONCLUSIONS: CivaSheet may be an acceptable alternative treatment modality compared to prior brachytherapy methods.

CivaSheet intraoperative radiation therapy for pancreatic cancer.

The treatment of borderline resectable (BR) pancreatic cancer is challenging and requires a multidisciplinary approach with chemotherapy, radiation and surgical resection. Despite using chemotherapy and radiotherapy in the neoadjuvant setting, achievement of negative surgical margins remains technically challenging. Positive margins are associated with increased local recurrences and worse overall survival and there are no standard options for treatment. The CivaSheet is an FDA-cleared implantable sheet with a matrix of unidirectional planar low-dose-rate (LDR) Palladium-103 (Pd-103) sources. The sources are shielded on one side with gold to spare radio-sensitive structures such as the bowel. The sheet can easily be customized and implanted at the time of surgery when there is concern for close or positive margins. The CivaSheet provides an interesting solution to target the region of close/positive margins after pancreatectomy. Here we discuss the physical properties, the dosimetry, clinical workflow and early patient outcomes with the CivaSheet in pancreatic cancer.

Algorithmic determination of source orientations for the CivaSheet directional brachytherapy device.

PURPOSE: The CivaSheet device uses multiple directionally shielded Pd-103 CivaDot sources to produce a directional planar dose distribution. In postplanning, manually digitizing the 3D source orientation is challenging because the 3D vector must be digitized by using 2D displayed images. The aim of this study is to develop an algorithm that will automatically determine the direction of each CivaDot source based on the location of sources adjacent to it. METHODS AND MATERIALS: The algorithm determines the source direction by averaging the normal directions of multiple local planes established by the adjacent sources. The algorithm was tested on a manually constructed CivaSheet-like device that was CT scanned in known flat geometries and two known curved geometries. Algorithmically determined source directions were compared with the known directions. The algorithm was also used on a postplan for a gynecological pelvic sidewall tumor bed implant and compared against manual digitization of the source directions. RESULTS: For the flat and curved test geometries, the average angular difference between the algorithm determined and known orientation was 1.2° ± 0.8° (flat geometry), 1.7° ± 2.1° (curve about vertical axis), and 2.3° ± 2.4° (curve about horizontal axis). For the patient case, results showed on average a 23.1° ± 10.8° difference between the manual digitized orientation and the algorithm's predicted orientation. CONCLUSIONS: The algorithm calculates the source orientation with accuracy better than 2.3° for the controlled experiments. In addition to its accuracy, the algorithm produces consistent results and lessens the difficult challenge of orienting the partially shielded sources.

Intraoperative implantation of a mesh of directional palladium sources (CivaSheet): Dosimetry verification, clinical commissioning, dose specification, and preliminary experience.

PURPOSE: To present the clinical commissioning of a novel 103Pd directional brachytherapy device (CivaSheet) for intraoperative radiation therapy. METHODS AND MATERIALS: Clinical commissioning for the CivaSheet consisted of establishing: (1) source strength calibration capabilities, (2) experimental verification of TG-43 dosimetry parameters, (3) treatment planning system validation, and (4) departmental practice for dose specification and source ordering. Experimental verification was performed in water with radiochromic film calibrated with a 37 kVp X-ray beam. Percentage difference ([measurements - calculation]/calculation) and distance to agreement (difference between film-to-source distance and distance that minimized the percentage difference) were calculated. Nomogram values (in U/100 Gy) for all configurations (up to 20 × 20 sources) were calculated for source ordering. Clinical commissioning was used on patients enrolled in an ongoing Institutional Review Board-approved protocol. RESULTS: A source calibration procedure was established, and the treatment planning system was commissioned within standard clinical uncertainties. Percentage dose differences (distances to agreement) between measured and calculated doses were 8.6% (-0.12 mm), 0.6% (-0.01 mm), -6.4% (0.22 mm), and -10.0% (0.44 mm) at depths of 2.3, 5.1, 8.0, and 11.1 mm, respectively. All differences were within the experimental uncertainties. Nomogram values depended on sheet size and spatial extent. A value of 2.4U/100 Gy per CivaDot was found to satisfy most cases, ranging from 2.3 to 3.3U/100 Gy. Nomogram results depended on elongation of the treatment area with a higher variation observed for smaller treatment areas. Postimplantation dose evaluation was feasible. CONCLUSIONS: Commissioning and clinical deployment of CivaSheet was feasible using BrachyVision for postoperative dose evaluation. Experimental verification confirmed that the available TG-43 dosimetry parameters are accurate for clinical use.

A directional 103Pd brachytherapy device: Dosimetric characterization and practical aspects for clinical use.

PURPOSE: A brachytherapy (BT) device has been developed with shielding to provide directional BT for preferentially irradiating malignancies while sparing healthy tissues. The CivaSheet is a flexible low-dose-rate BT device containing CivaDots with 103Pd shielded by a thin Au disk. This is the first report of a clinical dosimetric characterization of the CivaSheet device. METHODS AND MATERIALS: Radiation dose distributions near a CivaDot were estimated using the MCNP6 radiation transport code. CivaSheet arrays were also modeled to evaluate the dose superposition principle for treatment planning. The resultant data were commissioned in a treatment planning system (TPS) (VariSeed 9.0), and the accuracy of the dose superposition principle was evaluated for summing individual elements comprising a planar CivaSheet. RESULTS: The dose-rate constant (0.579 cGy/h/U) was lower than for 103Pd seeds due to Au L-shell x-rays increasing the air-kerma strength. Radial dose function values at 0.1, 0.5, 2, 5, and 10 cm were 1.884, 1.344, 0.558, 0.088, and 0.0046, respectively. The two-dimensional anisotropy function exhibited dramatic reduction between the forward (0°) and rearward (180°) directions by a factor of 276 at r = 0.1 cm, 24 at r = 1 cm, and 5.3 at r = 10 cm. This effect diminished due to increasingly scattered radiation. The largest gradient in the two-dimensional anisotropy function was in contact with the device at 92° due to the Au disk shielding. TPS commissioning and dose superposition accuracies were typically within 2%. CONCLUSIONS: Simulations of the CivaDot yielded comprehensive dosimetry parameters that were entered into a TPS and deemed acceptable for clinical use. Dosimetry measurements of the CivaSheet are also of interest to the BT community.