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Also known as [68Ga]GA-DOTA-TATE, GA-DOTA-TATE
Gallium 68 Dotatate · 1 trial · 1 indication
Subject-level sensitivity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP participants) among CIM positive participants (i.e. TP or FN participants). * TP participants were those who showed at least one lesion based on both \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM by central read. * FN participants were those who did not show any lesions based on \[68Ga\]Ga-DOTA-TATE PET/CT imaging but showed at least one lesion based on CIM by central read. True Positive \[TP\] False Positive \[FP\] False Negative \[FN\] True Negative \[TN\]
Subject-level specificity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN participants) among CIM negative participants (i.e. TN or FP participants). * TN participants were those who did not show any lesions based on both \[68Ga\]Ga-DOTA-TATE PET/CT imaging and CIM by central read. * FP participants were those who showed at least one lesion based on \[68Ga\]Ga-DOTA-TATE PET/CT imaging but did not show any lesions based on CIM by central read. True Positive \[TP\] False Positive \[FP\] False Negative \[FN\] True Negative \[TN\]
Subject-level sensitivity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP participants) among CIM positive participants (i.e. TP or FN participants). True Positive \[TP\] False Positive \[FP\] False Negative \[FN\] True Negative \[TN\] Sensitivity = TP / (TP + FN)
Subject-level specificity is defined as the proportion of \[68Ga\]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN participants) among CIM negative participants (i.e. TN or FP participants). True Positive \[TP\] False Positive \[FP\] False Negative \[FN\] True Negative \[TN\] Specificity = TN / (TN + FP).
| Arm | Type | Description |
|---|---|---|
| [68Ga]Ga-DOTA-TATE | EXPERIMENTAL | All eligible participants will receive \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
| Name | Type | Description |
|---|---|---|
| [68Ga]Ga-DOTA-TATE | DRUG | Single intravenous injection of \[68Ga\]Ga-DOTA-TATE determined by body weight (2 Mega-Becquerel (MBq) / kilogram (kg) (0.054 Millicurie (mCi)/kilogram (kg)) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)) at the imaging day (Day 1). |
| 68Ge/68Ga Generator | DRUG | Radionuclide generator |
Key Inclusion Criteria: 1. Signed informed consent must have been obtained prior to participation in the study 2. Participants must have been adults \>= 18 years of age 3. ECOG performance status 0-2 4. For patient with NENs only: Participants were to be confirmed NENs based on histopathology, imag...
Gallium 68 Dotatate is a diagnostic imaging agent used in patients with neuroendocrine neoplasms (NENs). It is a small molecule radiopharmaceutical that helps visualize these tumors during PET imaging. It is also studied in healthy volunteers as a comparator in imaging research. The drug is being developed by Novartis AG under ticker NVS.
Gallium 68 Dotatate targets somatostatin receptors, which are often overexpressed on neuroendocrine tumor cells. By binding to these receptors, the radioactive gallium-68 isotope allows positron emission tomography (PET) to detect and localize neuroendocrine neoplasms. This targeting mechanism underlies its use as a diagnostic imaging agent in oncology.
Gallium 68 Dotatate is developed by Novartis AG, which trades under the ticker NVS. Novartis is responsible for the clinical development and regulatory strategy of this imaging agent for neuroendocrine neoplasms.
Gallium 68 Dotatate is in Phase 3 clinical development. The only listed trial, NCT06240741, is a completed Phase 3 study. It is an investigational agent and has not been approved by the FDA for the studied indication based on the available information.
Gallium 68 Dotatate has been evaluated in one clinical trial: NCT06240741, titled "A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan." This Phase 3 trial is completed and enrolled 71 participants. It was an uncontrolled, non-randomized study conducted in Japan.
Yes, Gallium 68 Dotatate is also known as [68Ga]GA-DOTA-TATE, GA-DOTA-TATE, [68Ga]Ga-DOTA-TATE, and Ga-DOTA-TATE. These names refer to the same radiopharmaceutical imaging agent developed by Novartis AG for neuroendocrine neoplasms.