Real Time In-Vivo Body Surface Dosimetry for External Beam Radiation Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-13

Study Completion Date

2017-04-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is an observational study. This protocol will determine the feasibility of using a novel nano-material based fiber-optic dosimeter (nanoFOD) device, with dimensions less than 1 mm wide, to measure real-time, pin-point, in-vivo radiation dose given during external beam delivery of radiation therapy treatments.This new protocol is similiar in design to Pro00050297 with the significant difference being the monitoring will be performed during external baem radiotherapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors

NCT00311597

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1/PHASE2

Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma

NCT02795195

Nasopharyngeal Carcinoma

COMPLETED PHASE1/PHASE2

Multiple Respiration-Correlated Cone Beam Computed Tomography (CT) Scans to Reduce Target Positioning Errors in Radiotherapy Treatment of Thoracic Cancer

NCT00722605

Esophageal Cancer Lung Cancer

COMPLETED PHASE1/PHASE2

Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis

NCT01757717

Metastatic or Recurrent Lesions in the Spine Metastatic or Recurrent Lesions in the Pelvis

COMPLETED NA

Toward High Fidelity Adaptive Radiotherapy in the Thorax

NCT04731571

Carcinoma, Non-Small-Cell Lung

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The device is currently in use in an ongoing IRB approved protocol Pro00050297 "Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy". Brachytherapy is an integral part of the management of many gynecological cancers, which uses radioactive isotopes to deliver radiation treatment in close proximity to the target. The protocol uses the device in the setting of gynecologic brachytherapy to monitor real time doses, with a primary endpoint of feasibility and accuracy. Accrual is ongoing, however, the device has initially given consistent results, within 3% of the expected values. This initial experience is intentionally designed with the simplest geometry and positioning. This protocol has a similar design to the initial brachytherapy trial, but with the significant difference that the monitoring will be performed during external beam radiotherapy. Calibration procedures are different in this scenario, and the considerations of when and where dose monitoring will be useful are distinct from these considerations in brachytherapy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer of the Gastrointestinal, Genitourinary or Gynecologic Systems

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Novel nano-scintillatorfiber-optic dosimeter ( nanoFOD)

This is an observational study whose purpose is to determine the feasibility of using a novel nano-scintillator fiber-optic dosimeter ( nanoFOD) for real time dosimetric monitoring of external beam radiotherapy.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

nanoFOD

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically documented neoplasm of the pelvis (including gynecologic, gastrointestinal, and genitourinary origin).
* Planned external beam radiotherapy as part of standard of care treatment
* The radiotherapy plan involves the body surface
* Age \> 18 years
* Able to provide and execute informed consent

Exclusion Criteria

* Allergy or previous intolerance of skin adhesives
* Any clinical scenario in which the nanoFOD placement or reading would compromise the treatment efficacy, or endanger the patient in any way.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No