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Materials (Basel, Switzerland) Feb 2024There are more than 13,000 new cases of cervical cancer each year in the United States and approximately 245,000 survivors. External beam radiation and brachytherapy are...
There are more than 13,000 new cases of cervical cancer each year in the United States and approximately 245,000 survivors. External beam radiation and brachytherapy are the front-line treatment modalities, and 60% of patients develop vaginal damage and constriction, i.e., stenosis of the vaginal vault, greatly impeding sexual function. The incidence of vaginal stenosis (VS) following radiotherapy (RT) for anorectal cancer is 80%. VS causes serious quality of life (QoL) and psychological issues, and while standard treatment using self-administered plastic dilators is effective, acceptance and compliance are often insufficient. Based on published patient preferences, we have pursued the design of a soft inflatable dilator for treating radiotherapy-induced vaginal stenosis (VS). The critical component of the novel device is the dilator balloon wall material, which must be compliant yet able to exert therapeutic lateral force levels. We selected a commercially available silicone elastomer and characterized its stress-strain characteristics and hyperelastic properties. These parameters were quantified using uniaxial tensile testing and digital image correlation (DIC). Dilator inflation versus internal pressure was modeled and experimentally validated in order to characterize design parameters, particularly the dilator wall thickness. Our data suggest that an inflatable silicone elastomer-based vaginal dilator warrants further development in the context of a commercially available, well-tolerated, and effective device for the graded, controlled clinical management of radiotherapy-induced VS.
PubMed: 38473522
DOI: 10.3390/ma17051050 -
Technical Innovations & Patient Support... Mar 2024To evaluate the efficacy of the balloon spacer when used to reduce the radiation dose delivered to the rectum in prostate cancer patients undergoing external beam...
OBJECTIVE
To evaluate the efficacy of the balloon spacer when used to reduce the radiation dose delivered to the rectum in prostate cancer patients undergoing external beam radiotherapy.
METHOD
A single center retrospective analysis including 75 PC patients with localized T1-T3a disease who received balloon spacer followed by EBRT. Pre- and post-implantation computed tomography (CT) scans were utilized for treatment planning for standard EBRT (78-81 Gy in 1.8-2 Gy fractions). Rectal dosimetry was assessed using DVHs, and toxicities were graded with CTCAE v.4.
RESULTS
A median (IQR) prostate-rectum separation resulted in 1.6 cm (1.4-2.0) post balloon spacer implantation. Overall, 90.6 % (68/75) of patients had a clinically significant 25 % relative reduction in the rectal with a median relative reduction of 91.8 % (71.2-98.6 %) at rV70. Three (4.0 %) patients reported mild procedural adverse events, anal discomfort and dysuria. Within 90 days post-implantation, five patients (6.67 %) and 1 patient (1.33 %) reported grade 1 and grade 2 rectal toxicities (anal pain, constipation, diarrhea and hemorrhoids). Genitourinary (GU) grade 1 toxicity was reported in 37 patients (49.33 %), with only one patient (1.33 %) experiencing grade 2 GU toxicity. No grade ≥ 3 toxicity was reported.
CONCLUSION
Balloon spacer implantation effectively increased prostate-rectum separation and associated with dosimetric gains EBRT for PC stage T1-T3a. Further controlled studies are required to ascertain whether this spacer allows for radiotherapy dose escalation and minimizes gastrointestinal (GI) toxicity.
PubMed: 38322778
DOI: 10.1016/j.tipsro.2024.100237 -
Cancers Dec 2023Previous work has reported the design of a novel thermobrachytherapy (TBT) balloon implant to deliver magnetic nanoparticle (MNP) hyperthermia and high-dose-rate (HDR)...
Previous work has reported the design of a novel thermobrachytherapy (TBT) balloon implant to deliver magnetic nanoparticle (MNP) hyperthermia and high-dose-rate (HDR) brachytherapy after brain tumor resection, thereby their synergistic effect. This paper presents an evaluation of the robustness of the balloon device, compatibility of its heat and radiation delivery components, as well as thermal and radiation dosimetry of the TBT balloon. TBT balloon devices with 1 and 3 cm diameter were evaluated when placed in an external magnetic field with a maximal strength of 8.1 kA/m at 133 kHz. The MNP solution (nanofluid) in the balloon absorbs energy, thereby generating heat, while an HDR source travels to the center of the balloon via a catheter to deliver the radiation dose. A 3D-printed human skull model was filled with brain-tissue-equivalent gel for in-phantom heating and radiation measurements around four 3 cm balloons. For the experiments, a 1 cm diameter balloon was surgically implanted in the brains of three living pigs (40-50 kg). The durability and robustness of TBT balloon implants, as well as the compatibility of their heat and radiation delivery components, were demonstrated in laboratory studies. The presence of the nanofluid, magnetic field, and heating up to 77 °C did not affect the radiation dose significantly. Thermal mapping and 2D infrared images demonstrated spherically symmetric heating in phantom as well as in brain tissue. pig experiments showed the ability to heat well-perfused brain tissue to hyperthermic levels (≥40 °C) at a 5 mm distance from the 60 °C balloon surface.
PubMed: 38067387
DOI: 10.3390/cancers15235683 -
Journal of Contemporary Brachytherapy Apr 2023Locally recurrent prostate cancer after previous radiation therapy remains challenging. One of the curative options for these patients is salvage brachytherapy. There...
PURPOSE
Locally recurrent prostate cancer after previous radiation therapy remains challenging. One of the curative options for these patients is salvage brachytherapy. There are no reports available on the use of a biodegradable rectal balloon implantation (RBI) in combination with brachytherapy in patients with recurrent prostate cancer after previous radiotherapy.
CASE PRESENTATION
Here, we report on a patient with a local recurrence at five years after previous low-dose-rate brachytherapy with a prescribed dose of 145 Gray (Gy) for a low-risk prostate adenocarcinoma. The patient experienced grade 3 rectal toxicity, which was resolved at the time of local recurrence. He was treated with focal high-dose-rate (HDR) brachytherapy of 2 fr. × 13 Gy after RBI implantation. Four years post-salvage treatment, there was no evidence of biochemical recurrence according Phoenix definition, and no gastro-intestinal or genitourinary toxicity.
CONCLUSIONS
This case describes the use of RBI implantation in combination with a focal salvage HDR in a patient with recurrent disease, with significant initial grade 3 rectal toxicity after previous irradiation. The use of a biodegradable RBI proved to be a promising solution for such a patient; however, this method needs to be further investigated.
PubMed: 37215617
DOI: 10.5114/jcb.2023.126051 -
Cardiovascular Revascularization... Sep 2023Intracoronary brachytherapy (ICB) has mainly been used to treat in-stent restenosis following percutaneous coronary intervention and was virtually abandoned about...
BACKGROUND/PURPOSE
Intracoronary brachytherapy (ICB) has mainly been used to treat in-stent restenosis following percutaneous coronary intervention and was virtually abandoned about 20 years ago. However, patients treated with this strategy are still alive and some teams continue to perform this therapy. We aimed to investigate the very long-term clinical outcome of patients treated with ICB.
METHODS/MATERIALS
A total of 173 consecutive patients who had been treated with ICB at a large tertiary referral centre between 1998 and 2003 were included. The primary endpoint of the study was all-cause mortality. The secondary endpoints were as follows: occurrence of major adverse cardiac events (MACE, defined as all-cause death, non-fatal myocardial infarction, or target vessel revascularization), cardiac death, and presence of angina at the end of follow-up.
RESULTS
Patients' mean age at the time of ICB was 64 ± 10 years and 77 % were male. Restenosis (bare metal stent vs. balloon angioplasty) was the only indication for ICB. Unstable angina was present in 34 % of the patients. Follow-up was available for 166 patients. After a mean follow-up of 20 ± 1.3 years, 66 % of the patients had died (including 74 patients (67 %) with cardiac death). Cumulative MACE rate at 20 years was 96 %.
CONCLUSIONS
Very long-term follow-up of patients with in-stent restenosis treated with ICB confirmed a high all-cause mortality rate mainly due to cardiac causes and MACEs.
Topics: Humans; Male; Female; Brachytherapy; Follow-Up Studies; Treatment Outcome; Coronary Restenosis; Coronary Angiography; Stents; Constriction, Pathologic; Death
PubMed: 37087307
DOI: 10.1016/j.carrev.2023.04.009 -
BMC Research Notes Feb 2023In this study, it was aimed to evaluate the functionality to deliver different prescription dose except 20 Gy for the Xoft Axxent Ebt (electronic Brachytherapy) system...
PURPOSE
In this study, it was aimed to evaluate the functionality to deliver different prescription dose except 20 Gy for the Xoft Axxent Ebt (electronic Brachytherapy) system and analyzing the system in terms of radiation dosimetry in water and 0.9% isotonic Sodium Chloride (NaCl) solution.
MATERIALS AND METHODS
In the Xoft Axxent eBT, different prescription dose in single fraction were calculated for different balloon applicator volumes based on source position and irradiation times. EBT-XD Gafchromic film was calibrated at 6MV photon energy. A balloon applicator filled with 0.9% isotonic NaCl solution was used to deliver a radiation dose of 20 Gy, 16 Gy, 10 Gy on the applicator surface. Then the balloon applicator was filled with water and the same measurements were repeated. Finally, the balloon applicator was irradiated by positioning it at different distances in the water phantom to simulate the isodose contour.
RESULTS
At the time the balloon applicator was filled with water and 0,9% NaCl solution, the difference between the planned dose and the absorbed dose was ~ 2% vs. 15% for 30 cc, ~ 5% vs. 14% for 35 cc and ~ 3,5% vs. 10% for 40 cc respectively. Finally, the absorbed dose at a distance of 1 cm from the applicator surface was measured as 9.63 Gy.
CONCLUSION
In this study, it was showed that different prescription dose could be possible to deliver in the Xoft Axxent eBT system based on the standard plan. In addition, the absorbed dose was higher than the planned dose depending on the effective atomic number of NaCl solution comparing to water due to photoelectric effect in low energy photons. By measuring the dose distributions at different distances from the balloon applicator surface, the absorbed dose in tissue equivalent medium was determined and the isodose contours characteristics was simulated.
Topics: X-Rays; Sodium Chloride; Radiography; Saline Solution; Water; Radiation Dosage
PubMed: 36855193
DOI: 10.1186/s13104-023-06287-1 -
Journal of Contemporary Brachytherapy Dec 2022To compare the rectal and bladder doses using two different vaginal packing techniques among uterine cervical cancer patients receiving high-dose-rate (HDR)...
PURPOSE
To compare the rectal and bladder doses using two different vaginal packing techniques among uterine cervical cancer patients receiving high-dose-rate (HDR) intracavitary brachytherapy (ICBT).
MATERIAL AND METHODS
Forty-five patients with cervical cancer were randomized to receive two sessions of ICBT using tandem and ring applicator (Varian), following completion of pelvic external beam radiotherapy treatment. The procedure was performed with vaginal balloon plus gauze packing or vaginal gauze packing alone, each of which was used in one of two sessions. Sequence of the type of vaginal packing was chosen with computer-generated block randomization. A HDR dose of 8.5 Gy was prescribed to point A in all patients. Volumetric dose parameters, such as D, D, D, and D of the rectum and bladder were compared between the two techniques of vaginal packing.
RESULTS
The mean age of patients was 51 years. Majority (88%) of patients had locally advanced stages of cancer at baseline (stage IIB or more). Rectal doses were significantly less in combined packing technique (D: 7.52 Gy vs. 9.02 Gy, = 0.01; D: 6.46 Gy vs. 7.42 Gy, < 0.01; D: 5.91 Gy vs. 6.7 Gy, < 0.01; D: 5.29 Gy vs. 5.97 Gy, < 0.01). Bladder doses were higher in the combined packing technique (D: 11.20 Gy vs. 10.76 Gy, = 0.18; D: 9.64 Gy vs. 9.32 Gy, = 0.56; D: 8.64 Gy vs. 8.36 Gy, = 0.55; D: 7.56 vs. 7.33 Gy, = 0.55).
CONCLUSIONS
Combined vaginal packing resulted in statistically significant reduction in rectal radiation dose compared with standard vaginal gauze packing in high-dose-rate brachytherapy of cervix cancer using tandem and ring applicators.
PubMed: 36819474
DOI: 10.5114/jcb.2022.123975 -
JACC. Cardiovascular Interventions Feb 2023
Topics: Humans; Dissection, Ascending Aorta; Treatment Outcome; Percutaneous Coronary Intervention; Angioplasty, Balloon, Coronary; Stents; Coronary Angiography; Brachytherapy; Coronary Restenosis
PubMed: 36669983
DOI: 10.1016/j.jcin.2022.10.031 -
Diagnostics (Basel, Switzerland) Sep 2022Peripheral arterial disease (PAD) is an increasingly pathological condition that commonly affects the femoropopliteal arteries. The current fashionable treatment is... (Review)
Review
Peripheral arterial disease (PAD) is an increasingly pathological condition that commonly affects the femoropopliteal arteries. The current fashionable treatment is percutaneous transluminal angioplasty (PTA), often with stenting. However, the in-stent restenosis (ISR) rate after the stenting of the femoropopliteal (FP) district remains high. Many techniques have been proposed for the treatment of femoropopliteal ISR, such as intravascular brachytherapy, laser atherectomy, second stenting and drug-coated balloons angioplasty (DCB). DCB showed a significantly lower rate of restenosis and target lesions revascularization (TLR) compared to conventional PTA. However, further studies and multi-center RCTs with dedicated long-term follow-up are needed to verify the true efficiency of this approach. Nowadays, the correlation between PAD and inflammation biomarkers is well known. Multiple studies have shown that proinflammatory markers (such as C-reactive proteins) and the high plasma levels of microRNA could predict the outcomes after stent placement. In particular, circulating microRNA-320a, microRNA-3937, microRNA-642a-3p and microRNA-572 appear to hold promise in diagnosing ISR in patients with PAD, but also as predictors of stent patency. This narrative review intends to summarize the current knowledge on the value of circulating biomarkers as predictors of ISR and to foster the scientific debate on the advantages of using DCB in the treatment of ISR in the FP district.
PubMed: 36140608
DOI: 10.3390/diagnostics12092207 -
Reviews in Cardiovascular Medicine Feb 2022Vascular brachytherapy (VBT) used to be an effective treatment modality for management of in-stent stenosis but was superceded by drug eluting stents (DES) which had...
BACKGROUND
Vascular brachytherapy (VBT) used to be an effective treatment modality for management of in-stent stenosis but was superceded by drug eluting stents (DES) which had shown a greater efficacy. However, there is no clear evidence to support superior management for in-stent restenosis (ISR) which continues to be a challenge.
METHODS
We conducted a systematic review of the literature and appraised PubMed, Medline, Web of science, ProQuest and Cochrane databases from 2000 to 2020. We assessed comparative outcomes including efficacy (as assessed by measuring major adverse cardiac events, target vessel revascularisation, target lesion revascularisation, all-cause mortality, target lesion myocardial infarction and stent thrombosis) and safety of VBT.
RESULTS
Of 1083 records obtained, a total of 8 retrospective studies met the inclusion criteria. In the included studies, major adverse cardiac events (MACE) rates ranged from 10% to 17.5% in the VBT group compared to 14.1% to 28.2% in the re-DES group at one year follow up. There were lower rates of target vessel revascularisation (VBT 10-22.8%; control 18-22.9%) and target lesion revascularisation (VBT 10-14.1%, Control 8-22.1%) between the VBT and re-DES groups. There were significantly low rates of all-cause mortality (1-5.4%), target lesion myocardial infarction (0-7%) and stent thrombosis (0-2.1%) in the VBT group at one year.
CONCLUSIONS
VBT is considered to be an effective and safe treatment strategy in complex patients with multiple risk factors for DES-ISR in initial reports. There are no long-term comparison studies available beyond 1 year. There is a need for randomised controlled trials to objectively assess the role of VBT compared to DES and drug coated balloons.
Topics: Brachytherapy; Coronary Restenosis; Drug-Eluting Stents; Humans; Retrospective Studies; Risk Factors; Treatment Outcome
PubMed: 35229545
DOI: 10.31083/j.rcm2302054