Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582342
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Is the 3D-PANC MSP Model Superior to CT for Assessing Response to Neoadjuvant Treatment in PCA Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Is 3-D Imaging Technology Superior to Computed Tomography in Assessing Response to Neoadjuvant Treatment in Patients With Borderline or Locally Advanced Pancreatic Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective multicenter study in which all patients with borderline or locally advanced pancreatic adenocarcioma undergoing neoadjuvant chemotherapy and surgical exploration with curative intent will be included for one year Preoperative images by traditional CT and 3D-MSP technology will be evaluated comparing the accuracy variables sensitivity specificity predictive values area under the curve concordance index of both techniques with the gold standard results of surgery and histopathological analysis
Detailed Description:
Neoadjuvant chemotherapy followed by surgery represents the treatment of choice for patients with borderline and locally advanced pancreatic adenocarcinoma PAC Despite being the diagnostic technique of choice for PAC staging computed tomography CT has a very low accuracy in detecting those patients who may benefit from surgical resection after neoadjuvant chemotherapy Consequently the study of computerized image processing technologies is gaining importance However there are no prospective validation studies of these technologies to determine their usefulness in the preoperative evaluation of PCA patients undergoing neoadjuvant therapy
A prospective multicenter study in which all patients with borderline or locally advanced PAC undergoing neoadjuvant chemotherapy and surgical exploration with curative intent will be included for one year Preoperative images by traditional CT and 3D-MSP technology will be evaluated comparing the accuracy variables sensitivity specificity predictive values area under the curve concordance index of both techniques with the gold standard results of surgery and histopathological analysis
A prospective multicenter study with control group will be performed Since this is the evaluation of a diagnostic test it will not be necessary to randomize the patients included since each patient will be evaluated by means of both techniques under study thus serving as his or her own control
A prospective multicenter study in which all patients with borderline or locally advanced PAC undergoing neoadjuvant chemotherapy and surgical exploration with curative intent will be included for one year Preoperative images by traditional CT and 3D-MSP technology will be evaluated comparing the accuracy variables sensitivity specificity predictive values area under the curve concordance index of both techniques with the gold standard results of surgery and histopathological analysis
A prospective multicenter study with control group will be performed Since this is the evaluation of a diagnostic test it will not be necessary to randomize the patients included since each patient will be evaluated by means of both techniques under study thus serving as his or her own control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None