Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460467
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-11
Brief Title:
Semi-automatic Segmentation Method for Determining 177Lu-DOTATATE Tumor Dosimetry
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Semi-automatic Segmentation Method for Determining 177Lu-DOTATATE Tumor Dosimetry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
SSTR
Brief Summary:
The aim of this study was to compare a semi-automatic segmentation method with manual reference segmentation to determine an overall tumor volume on post-therapy scintigraphy at D1 in patients treated with 177Lu-DOTATATE for meningioma or neuroendocrine tumor for dosimetric calculation
Detailed Description:
The new wide-field solid-state cameras enable quantitative single-photon emission tomoscintigraphy SPECT acquisitions particularly during internal vectorized radiotherapy treatments These innovative treatments are mainly used in cancer therapy They involve the injection of a radiopharmaceutical consisting of a vector specifically targeting the tumor cell - in this case somatostatin analogues targeting somatostatin receptors - and a radioactive isotope emitting β- or α-radiation to kill the tumor cell and γ-radiation for SPECT imaging - in this case 177Lu These radiopharmaceuticals are currently prescribed at fixed doses for all patients With the aim of personalized medicine tumor dosimetry is essential for predicting efficacy and dose-response relationships at the individual level of this type of treatment In view of the increasing therapeutic applications of these 177Lu therapies the European Association of Nuclear Medicine EANM has recently issued recommendations on the dosimetry of 177Lu-labeled somatostatin analogues Lutathéra 177Lu-DOTATATE among others
Nevertheless these recommendations are precise as regards dosimetry to organs at risk but remain unclear as regards tumor dosimetry Tumor dosimetry is therefore difficult to implement on a routine clinical basis
The efficacy of 177Lu-DOTATATE treatment has been demonstrated for neuroendocrine tumors in the NETTER-1 phase 3 study and interesting results have been reported for the treatment of refractory meningiomas
Furthermore a recent study showed that in patients with gastrointestinal neuroendocrine tumors treated with 177Lu-DOTATATE tumor dosimetry could predict patient survival
In order to optimize a dosimetric approach in clinical routine several steps are necessary i define a standardized manual or semi-automated segmentation method for determining the volumes of interest tumor volume andor organs at risk ii precisely quantify tumor or organs at risk volume activities over time and iii determine the doses absorbed by the tumor andor organs at risk
An initial study was conducted in the department of nuclear medicineto define a semi-automatic segmentation method for meningiomas treated with 177Lu-DOTATATE on pre-therapeutic 68Ga-DOTATOC positons emission tomography PET with the aim of predicting tumor dosimetry from pretherapeutic imaging For this study tumor segmentation will be performed directly on SPECT imaging carried out post-treatment on a 360 wide-field CZT camera to determine tumor dosimetry
The aim of this study is to compare a semi-automatic segmentation method with manual reference segmentation to determine overall tumor volume on post-therapy scintigraphy at D1 in patients treated with 177Lu-DOTATATE for meningioma or neuroendocrine tumor with a view to dosimetric calculation
Nevertheless these recommendations are precise as regards dosimetry to organs at risk but remain unclear as regards tumor dosimetry Tumor dosimetry is therefore difficult to implement on a routine clinical basis
The efficacy of 177Lu-DOTATATE treatment has been demonstrated for neuroendocrine tumors in the NETTER-1 phase 3 study and interesting results have been reported for the treatment of refractory meningiomas
Furthermore a recent study showed that in patients with gastrointestinal neuroendocrine tumors treated with 177Lu-DOTATATE tumor dosimetry could predict patient survival
In order to optimize a dosimetric approach in clinical routine several steps are necessary i define a standardized manual or semi-automated segmentation method for determining the volumes of interest tumor volume andor organs at risk ii precisely quantify tumor or organs at risk volume activities over time and iii determine the doses absorbed by the tumor andor organs at risk
An initial study was conducted in the department of nuclear medicineto define a semi-automatic segmentation method for meningiomas treated with 177Lu-DOTATATE on pre-therapeutic 68Ga-DOTATOC positons emission tomography PET with the aim of predicting tumor dosimetry from pretherapeutic imaging For this study tumor segmentation will be performed directly on SPECT imaging carried out post-treatment on a 360 wide-field CZT camera to determine tumor dosimetry
The aim of this study is to compare a semi-automatic segmentation method with manual reference segmentation to determine overall tumor volume on post-therapy scintigraphy at D1 in patients treated with 177Lu-DOTATATE for meningioma or neuroendocrine tumor with a view to dosimetric calculation
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