Ignite Creation Date:
2024-05-06 @ 1:13 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03964064
Status:
UNKNOWN
Last Update Posted:
2019-07-19
First Post:
2019-05-21
Brief Title:
I125 Seed Implantation vs Stereotactic Radiotherapy for Pancreatic Cancer
Sponsor:
Peking University Third Hospital
Organization:
Peking University Third Hospital
Study Overview
Official Title:
3D-printing Template-assisted CT-guided I125 Seed Implantation and Stereotactic Radiotherapy for Locally Advanced Pancreatic CancerA Prospective Multicenter Cohort Study
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ckvssip
Brief Summary:
Data of 100 patients with locally advanced pancreatic cancer who received stereotactic radiotherapy or ct-guided radioactive 125I seed implantation in the multicenter of the research group from July 2019 to June 2021 were collected as well as follow-up dataTo evaluate the clinical efficacy of stereotactic radiotherapy and ct-guided 125I seed therapy with 3D printing template in pancreatic cancerIn addition the local control rate and side effects of ct-guided radioactive 125I particles in the treatment of pancreatic cancer lesions were explored and the efficacy and safety of different doses of stereotactic radiotherapy were determined
Detailed Description:
1 Radiation Stereotactic Radiotherapy 11 Equipment Accuray VSI Cyberknife stereotactic radiotherapy platform simulated positioning CT machine MR positron emission computed tomography PET-CT vacuum pad
12 Radiotherapy localization CT MRI and PETCT were used to simulate localization
13 Relevant Definitions of Tumor Targets CT MRI PET-CT fusion combined with MRI location and PET-CT location image for sketching
To delineate target areas and organs at risk GTV Combining localization and fusion images to delineate the tumors seen PTV GTV 0-10mm Dangerous organs The stomach duodenum jejunum ileum colon spinal cord and esophagus were delineated on the base sequence of CT plain scan
The target area should be approved by at least one physician in charge or by a physician in charge
14 Target volume radiation dose According to the volume location organ function and other factors the dosage of radiotherapy was determined The range of BED value of radiotherapy was 80-100 when the distance between the tumor and gastrointestinal tract was more than 5 mm alphabeta10 and 60-80 when the distance between the tumor and gastrointestinal tract was less than 5 mm alphabeta10
15 Normal Tissue Limit Reference to TG101 Report
2 CT-guided radioactive 125I seeds therapy with 3D printing template for pancreatic cancer 21 Preoperative planning 22 Design and fabrication of 3D-PNCT 23 125I seeds implantation 3D-PNCT was placed on the surface of the patients treatment area and positioned with the help of the patients outline features laser lines body surface positioning lines and template alignment reference lines
The location of the template and the tumor is well repeated If there are errors the template should be adjusted in time The insertion needle was percutaneously punctured to a predetermined depth through a template guide hole During the puncture process the puncture path was monitored by CT scanning and fine-tuned if necessary to avoid injuring nerves and blood vessels Seeds implantation and CT scan were performed according to the preoperative plan to understand the distribution of seeds During the operation the implant needle should be added or reduced when necessary to ensure that the whole target area is adequately irradiated and the surrounding normal tissues are protected
24 Postoperative dose assessment CT scan was performed after operation and the image was transmitted to BTPS for dose verification Figure 3-4 The dosimetric parameters included tumor volume D90 mPD V100 V150 and V200
After these treatmentsto evaluate the clinical efficacy of stereotactic radiotherapy and ct-guided 125I seed therapy with 3D printing template in pancreatic cancerIn addition the local control rate and side effects of ct-guided radioactive 125I particles in the treatment of pancreatic cancer lesions were explored and the efficacy and safety of different doses of stereotactic radiotherapy were determined
12 Radiotherapy localization CT MRI and PETCT were used to simulate localization
13 Relevant Definitions of Tumor Targets CT MRI PET-CT fusion combined with MRI location and PET-CT location image for sketching
To delineate target areas and organs at risk GTV Combining localization and fusion images to delineate the tumors seen PTV GTV 0-10mm Dangerous organs The stomach duodenum jejunum ileum colon spinal cord and esophagus were delineated on the base sequence of CT plain scan
The target area should be approved by at least one physician in charge or by a physician in charge
14 Target volume radiation dose According to the volume location organ function and other factors the dosage of radiotherapy was determined The range of BED value of radiotherapy was 80-100 when the distance between the tumor and gastrointestinal tract was more than 5 mm alphabeta10 and 60-80 when the distance between the tumor and gastrointestinal tract was less than 5 mm alphabeta10
15 Normal Tissue Limit Reference to TG101 Report
2 CT-guided radioactive 125I seeds therapy with 3D printing template for pancreatic cancer 21 Preoperative planning 22 Design and fabrication of 3D-PNCT 23 125I seeds implantation 3D-PNCT was placed on the surface of the patients treatment area and positioned with the help of the patients outline features laser lines body surface positioning lines and template alignment reference lines
The location of the template and the tumor is well repeated If there are errors the template should be adjusted in time The insertion needle was percutaneously punctured to a predetermined depth through a template guide hole During the puncture process the puncture path was monitored by CT scanning and fine-tuned if necessary to avoid injuring nerves and blood vessels Seeds implantation and CT scan were performed according to the preoperative plan to understand the distribution of seeds During the operation the implant needle should be added or reduced when necessary to ensure that the whole target area is adequately irradiated and the surrounding normal tissues are protected
24 Postoperative dose assessment CT scan was performed after operation and the image was transmitted to BTPS for dose verification Figure 3-4 The dosimetric parameters included tumor volume D90 mPD V100 V150 and V200
After these treatmentsto evaluate the clinical efficacy of stereotactic radiotherapy and ct-guided 125I seed therapy with 3D printing template in pancreatic cancerIn addition the local control rate and side effects of ct-guided radioactive 125I particles in the treatment of pancreatic cancer lesions were explored and the efficacy and safety of different doses of stereotactic radiotherapy were determined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None