Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06460467 |
| Other study ID # |
2024PI103 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
July 1, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Central Hospital, Nancy, France |
| Contact |
Boursier Caroline, MD |
| Phone |
+33383154039 |
| Email |
c.boursier[@]chru-nancy.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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 and/or organs at risk), ii) precisely quantify tumor or
organs at risk volume activities over time, and iii) determine the doses absorbed by the
tumor and/or organs at risk.
An initial study was conducted in the department of nuclear medicine,to 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.
