Trial Summary
What is the purpose of this trial?This trial is testing a new imaging scan for patients with specific types of tumors. The scan uses a special substance to make the tumors more visible. It aims to provide better images for accurate diagnosis and monitoring.
Is 68Ga-HA-DOTATATE a promising treatment for neuroendocrine tumors?Yes, 68Ga-HA-DOTATATE is a promising treatment for neuroendocrine tumors because it helps doctors see these tumors more clearly than traditional methods. This can lead to better management and treatment decisions for patients.12457
What safety data is available for 68Ga-DOTATATE imaging in neuroendocrine tumors?The provided research does not directly address safety data for 68Ga-DOTATATE imaging. The studies focus on its diagnostic value, management impact, and quality control in neuroendocrine tumor imaging. Safety data might be available in other studies or clinical trial reports specifically evaluating adverse effects or safety profiles of 68Ga-DOTATATE.13467
What data supports the idea that 68Ga-HA-DOTATATE Imaging for Neuroendocrine Tumors is an effective treatment?The available research shows that 68Ga-HA-DOTATATE Imaging is effective for neuroendocrine tumors because it provides more detailed information than traditional imaging methods. One study highlights its advantages over conventional imaging and another type of imaging called In-111 octreotide, which helps doctors make better decisions about patient care. Another study found that 68Ga-HA-DOTATATE Imaging is better than CT scans for managing these tumors. This means it can more accurately identify and assess the tumors, leading to improved treatment planning. Additionally, it has been successfully used to identify rare types of neuroendocrine tumors, like those in the sinonasal area, which are difficult to detect with other methods.14578
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.
Eligibility Criteria
This trial is for patients with suspected or confirmed somatostatin receptor positive tumors, such as certain neuroendocrine tumors. Participants must have had a CT or MRI within the last 6 months and be able to consent. It's not for those who've had allergic reactions to DOTATATE, weigh over 225 kg, can't lie still for imaging due to conditions like extreme claustrophobia, or lack intravenous access.Treatment Details
The study tests the safety and diagnostic effectiveness of a new imaging agent called 68Ga-HA-DOTATATE in detecting somatostatin receptor positive tumors using PET scans. This could potentially offer better image quality and accuracy compared to older methods.
1Treatment groups
Experimental Treatment
Group I: 68Ga-HA-DOTATATE PET/CT scanExperimental Treatment1 Intervention
2.64 MBq/kg (minimum 37 MBq, maximum 250 MBq) 68Ga-HA-DOTATATE intravenous single-dose administration for PET/CT imaging
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of AlbertaEdmonton, Canada
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Who is running the clinical trial?
University of AlbertaLead Sponsor
References
High management impact of Ga-68 DOTATATE (GaTate) PET/CT for imaging neuroendocrine and other somatostatin expressing tumours. [2022]Ga-68 DOTATATE (Ga-octreotate, GaTate) positron emission tomography (PET)/CT has multiple advantages compared with conventional and In-111 octreotide imaging for neuroendocrine tumours and other somatostatin-receptor expressing tumours. This study assesses the management impact of incremental diagnostic information obtained from this technique compared with conventional staging.
Neuroendocrine tumor recurrence: diagnosis with 68Ga-DOTATATE PET/CT. [2022]To evaluate diagnostic performance of gallium 68-tetraazacyclododecane tetraacetic acid-octreotate ((68)Ga-DOTATATE) in detection of recurrent neuroendocrine tumors (NETs).
The Rate and Clinical Significance of Incidental Thyroid Uptake as Detected by Gallium-68 DOTATATE Positron Emission Tomography/Computed Tomography. [2019]Gallium-68 (Ga-68) DOTATATE is a radiolabeled peptide-imaging modality that targets the somatostatin receptor (SSTR), especially subtype 2 (SSTR2). Benign and malignant thyroid tumors have been observed to express SSTR. The aim of this study was to evaluate the frequency and clinical significance of incidental atypical thyroid uptake as detected by Ga-68 DOTATATE positron emission tomography/computed tomography (PET/CT).
Gallium-68-dotatate PET/CT is better than CT in the management of somatostatin expressing tumors: First experience in Africa. [2019]Label="OBJECTIVE" NlmCategory="OBJECTIVE">In this study we aimed to present our experience on the use of Gallium-68-dotatate with positron emission tomography, computed tomography (68 Ga-dotatate PET/CT) in the management of neuroendocrine tumors (NET) and other somatostatin expressing tumors.
Ga-68 DOTATATE PET/CT and F-18 FDG PET/CT in the evaluation of low and intermediate versus high-grade neuroendocrine tumors. [2021]We investigated the role of Ga-68 DOTATATE PET/CT in comparison to F-18 FDG PET/CT in patients with low and intermediate versus high-grade neuroendocrine tumors (NETs).
Validation of Quality Control Parameters of Cassette-Based Gallium-68-DOTA-Tyr3-Octreotate Synthesis. [2022]Gallium (Ga)-68-DOTA peptides targeting somatostatin receptors have been assessed as a valuable tool in neuroendocrine tumor imaging using positron emission tomography. However, at the moment, a specific monograph in the European Pharmacopoeia (Ph. Eur.) does exist only for Ga-68-edotreotide (DOTATOC) injection. Here, we report on the validation process of Ga-68-DOTA-Tyr3-octreotate (DOTATATE) cassette-based production and quality control (QC).
The value of 68 Gallium-DOTATATE PET/CT in sinonasal neuroendocrine tumor management: A case series. [2021]Label="BACKGROUND"> 68 Gallium-DOTATATE (68 Ga-DOTATATE) is a somatostatin analog used as a PET tracer to successfully identify neuroendocrine tumors (NETs). Due to the rarity of sinonasal NETs, there are few recommendations for 68 Ga-DOTATATE imaging in these patients.
Unusual Increased Blood Pool Activity on 68Ga-DOTATATE PET/CT in a Patient With Metastatic Neuroendocrine Disease. [2023]68Ga-DOTATATE is a well-established, positron-emitting, somatostatin receptor-binding radiopharmaceutical. We present an unusual case of transiently increased blood pool uptake of 68Ga-DOTATATE in a patient with well-differentiated stage IV neuroendocrine tumor, with Ki-67