Clinical evaluation of the novel, uni-directional, Pd-103 CivaSheet for Lung Cancer
新型单向 Pd-103 CivaSheet 用于肺癌的临床评估
基本信息
- 批准号:10250609
- 负责人:
- 金额:$ 0.06万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2017
- 资助国家:美国
- 起止时间:2017-09-13 至 2021-08-31
- 项目状态:已结题
- 来源:
- 关键词:Absorbable ImplantsAcuteApplications GrantsBrachytherapyCancer PatientChestChest wall structureClinicalClinical TrialsDataDevicesDiseaseDoseDose-LimitingEffectivenessEncapsulatedExcisionExternal Beam Radiation TherapyGoldGrantHeartImplantInjuryInstitutionInstructionLobeLobectomyLocalized Malignant NeoplasmLocationLungMalignant NeoplasmsMalignant neoplasm of lungMediastinumMembraneMethodsMissionMonitorMovementNational Comprehensive Cancer NetworkNew York CityOncologyOperative Surgical ProceduresOrganOutcomeOverdosePainPalladium 103PatientsPhasePolymersPositioning AttributeProceduresProtocols documentationQuality of lifeRadiationRadiation Dose UnitRadiation OncologistRadiation ToleranceRadiation therapyReadinessRecommendationRecurrenceReportingResearch PersonnelResectedRiskSafetySideSiteSourceStatistical Data InterpretationStructureSurgeonSurgical marginsTechniquesTestingTherapeutic EffectTimeTimeLineTissuesToxic effectTrainingTumor TissueVertebral columnWorkX-Ray Computed Tomographyappropriate dosearmcancer therapyclinical research sitecohortcost effectivedosimetryfollow-upimplantable deviceimplantationimprovedin vivoinfection risklung lobeminimally invasivemortalitynovelpatient populationprimary endpointrecruitresearch clinical testingside effectstandard of caretumor
项目摘要
CivaTech Oncology’s mission is to provide improved radiation therapy directly to localized
tumors. The Company has developed a novel, polymer-encapsulated, membrane-like radiation source
that emits radiation on only one side of the device – the CivaSheet. This directional source is compatible
with open and minimally invasive surgical techniques and has FDA clearance to be used as primary or
combined cancer therapy. The CivaSheet is a partially bio-absorbable implant that can be applied at the
time of the initial surgery. The CivaSheet decreases the time between surgery and radiation therapy,
which is a benefit to the patient. Additionally, the CivaSheet can shield healthy tissues while irradiating
the diseased tissue or tumor margin. This shielding enables the CivaSheet to be implanted close to
radiosensitive structures without overdosing them – a potential advantage for cancers in the thorax.
In Phase I, CivaTech Oncology will confirm the CivaSheet does not move after implantation and
that excellent dosimetry can be achieved. The CivaSheet will be implanted during lung lobe
segmentation or wedge resection – a standard of care procedure for lung cancer patients who cannot
tolerate full lobectomy. The CivaSheet will benefit these patients by delivering radiation therapy at the
time of initial surgery to minimize delay in the treatment. For lung cancer patients complete lobectomy
is preferred for patients who can tolerate it. For those who cannot, radiation to the surgical margin is a
potential benefit. In Phase I, the safety of CivaSheet and general recommendations for its use in this
patient population will be assessed. Changes to the surgical implant technique will be assessed as well.
The Phase II will consist of two concurrent clinical trials exploring the use of the CivaSheet as
boost radiation therapy in lung cancer patients. The rate of local recurrence in patients implanted with
CivaSheet will be compared to the current rate of 20%. Additionally, the quality of life, pain, and
mortality in each patient will be monitored. CivaSheet will reduce the radiation delivered to adjacent
mediastinum and therefore should result in fewer side effects. Additionally, it will provide a conformal
dose, reduce the risk for infection, and possibly reduce treatment related side effects.
CivaSheet is a truly unique brachytherapy device that has the potential to become the first line
of defense for localized cancer. CivaTech Oncology is committed to making the CivaSheet available to
cancer patients in multiple indications.
CivaTech Oncology的使命是提供直接针对局部的改进放射治疗
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Kristy Perez其他文献
Kristy Perez的其他文献
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{{ truncateString('Kristy Perez', 18)}}的其他基金
Administrative Supplement for the Evaluation of the novel, uni-directional, Pd-103 CivaSheet for Lung Cancer
用于评估新型单向 Pd-103 CivaSheet 治疗肺癌的行政补充
- 批准号:
10310817 - 财政年份:2021
- 资助金额:
$ 0.06万 - 项目类别:
Clinical evaluation of the novel, uni-directional, Pd-103 CivaSheet for Pancreatic Cancers
新型单向 Pd-103 CivaSheet 用于胰腺癌的临床评估
- 批准号:
9558651 - 财政年份:2017
- 资助金额:
$ 0.06万 - 项目类别:
Commercializing CivaSheet for Pancreatic Cancer Patients
将 CivaSheet 商业化用于胰腺癌患者
- 批准号:
10684454 - 财政年份:2016
- 资助金额:
$ 0.06万 - 项目类别:
Clinical evaluation of the novel, uni-directional, Pd-103 CivaSheet for Pancreatic Cancers
新型单向 Pd-103 CivaSheet 用于胰腺癌的临床评估
- 批准号:
9200280 - 财政年份:2016
- 资助金额:
$ 0.06万 - 项目类别:
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