Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133543
Status:
RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-11-10
Brief Title:
Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
Sponsor:
Heinrich-Heine University Duesseldorf
Organization:
Heinrich-Heine University Duesseldorf
Study Overview
Official Title:
RAISN - Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
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:
RAISN
Brief Summary:
Robot-assisted image-guided sentinel lymph node biopsy RAISN in testicular cancer is a novel technique that has not been widely investigated yet This technique is promising and could be implemented as a future standard in the primary diagnostic work up of clinical stage CS I testicular cancer Current staging strategies have a poor predictive accuracy for occult metastatic disease
So far feasibility studies used 99mTC-nanocolloid staining and laparoscopy and all patients with tumor-positive nodes received adjuvant systemic treatment The development of a robot-assisted image-guided lymph node resection technique with indocyanine green ICG is potentially more precise easier to apply and widely available With this new diagnostic approach the management of newly diagnosed testicular cancer patients might be changed dramatically by reducing overtreatment and treatment-related toxicity with a minimally invasive robot-assisted procedure
So far feasibility studies used 99mTC-nanocolloid staining and laparoscopy and all patients with tumor-positive nodes received adjuvant systemic treatment The development of a robot-assisted image-guided lymph node resection technique with indocyanine green ICG is potentially more precise easier to apply and widely available With this new diagnostic approach the management of newly diagnosed testicular cancer patients might be changed dramatically by reducing overtreatment and treatment-related toxicity with a minimally invasive robot-assisted procedure
Detailed Description:
The sentinel lymph node biopsy in testicular cancer is a novel technique that has not been extensively studied This technique shows promise and could potentially become the future standard in the primary diagnosis of testicular cancer in clinical stage I
In cases of clinical stage I testicular cancer 20 to 30 of patients experience a recurrence Strategies such as adjuvant chemotherapy or retroperitoneal lymph node dissection can reduce the risk of recurrence to 2 and 9 respectively However the issue with these strategies is that the majority of patients may receive unnecessary treatment and endure the toxicity of chemotherapy or surgery German and European guidelines recommend a risk-adapted approach Testicular tumor patients with specific histopathological features are classified into low and high risk with adjuvant therapy recommended accordingly This strategy allows for more targeted treatment but still maintains a limited sensitivity of approximately 73
There have been few studies investigating the possibility of sentinel lymph node diagnostics in testicular cancer Reasons for this include the rarity of the disease coupled with a lack of experience in minimally invasive surgery for testicular cancer treatment Previous sentinel lymph node studies utilized the radioligand technique with technetium which was limited to centers with a nuclear medicine department With the advancing development of robotics and fluorescence technology using indocyanine green there is an opportunity for a novel minimally invasive lymph node diagnostic method applicable on a broader scale for testicular cancer patients
In previous feasibility studies on sentinel lymph node diagnostics in testicular tumor patients the use of 99mTC-nanocolloid staining and laparoscopy achieved a 90 sensitivity The development of a robot-assisted image-guided lymph node resection technique using indocyanine green ICG is potentially more precise easier to apply and generally more available Multiple studies in other tumor entities have demonstrated the non-inferiority and superiority of ICG over technetium This new diagnostic approach could drastically change the treatment for newly diagnosed testicular cancer patients by reducing overtreatment and treatment-related toxicity through a minimally invasive robot-assisted procedure
In cases of clinical stage I testicular cancer 20 to 30 of patients experience a recurrence Strategies such as adjuvant chemotherapy or retroperitoneal lymph node dissection can reduce the risk of recurrence to 2 and 9 respectively However the issue with these strategies is that the majority of patients may receive unnecessary treatment and endure the toxicity of chemotherapy or surgery German and European guidelines recommend a risk-adapted approach Testicular tumor patients with specific histopathological features are classified into low and high risk with adjuvant therapy recommended accordingly This strategy allows for more targeted treatment but still maintains a limited sensitivity of approximately 73
There have been few studies investigating the possibility of sentinel lymph node diagnostics in testicular cancer Reasons for this include the rarity of the disease coupled with a lack of experience in minimally invasive surgery for testicular cancer treatment Previous sentinel lymph node studies utilized the radioligand technique with technetium which was limited to centers with a nuclear medicine department With the advancing development of robotics and fluorescence technology using indocyanine green there is an opportunity for a novel minimally invasive lymph node diagnostic method applicable on a broader scale for testicular cancer patients
In previous feasibility studies on sentinel lymph node diagnostics in testicular tumor patients the use of 99mTC-nanocolloid staining and laparoscopy achieved a 90 sensitivity The development of a robot-assisted image-guided lymph node resection technique using indocyanine green ICG is potentially more precise easier to apply and generally more available Multiple studies in other tumor entities have demonstrated the non-inferiority and superiority of ICG over technetium This new diagnostic approach could drastically change the treatment for newly diagnosed testicular cancer patients by reducing overtreatment and treatment-related toxicity through a minimally invasive robot-assisted procedure
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?:
None
Is an FDA AA801 Violation?:
None