68Ga-DOTATATE PET for Management of Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT03873870|
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Diagnostic Test: 68Ga -DOTATATE PET scans||Not Applicable|
When patients are suspected of having neuroendocrine tumours, they will usually undergo various imaging scans such as computed tomography (CT) scan and magnetic resonance imaging (MRI), and octreotide scintigraphy (octreoscan) to try to identify the primary tumour. During the patients' course of disease, they will continue to have various CT, MRI, and/or octreoscans. Sometimes, despite using scans, laboratory tests, and examination, it is still difficult to properly diagnose neuroendocrine tumours.
Doctors have found that most neuroendocrine tumours make too much of a hormone called somatostatin on their cell surface. Because of this doctors have been using positron emission tomography (PET) scans using a special contrast dye called 68Ga-DOTATATE in hopes of better diagnosing and managing neuroendocrine tumours. 68Ga-DOTATATE can label the cells that have somatostatin (such as neuroendocrine tumour cells) so that the PET scan can take better pictures and doctors can better diagnose and manage the disease.
However, despite 68Ga-DOTATATE PET scans showing promise, it is still not widely accessible. Because of this, researchers are creating a registry for patients who may need 68Ga-DOTATATE PET scans to:
- Identify their primary tumour where the doctor suspects is a neuroendocrine tumour
- Staging of the neuroendocrine tumour
- Restage the tumour prior to surgery/radiotherapy or help to assess the tumour where standard scans such as CTs, MRIs, or octreoscans are not properly showing your tumours despite other clinical or laboratory tests showing that your disease has progressed
- For other issues when confirmation of site of disease and/or disease extent may impact clinical management of the neuroendocrine tumour.
This registry help the participant's treating physician to obtain approval for the participant to undergo 68Ga-DOTATATE PET scans for their neuroendocrine tumour.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Clinical Impact of 68Ga-DOTATATE PET in the Management of Patients With Neuroendocrine Tumors|
|Actual Study Start Date :||March 28, 2019|
|Estimated Primary Completion Date :||April 1, 2024|
|Estimated Study Completion Date :||October 1, 2024|
|Experimental: 68Ga -DOTATATE PET scan||
Diagnostic Test: 68Ga -DOTATATE PET scans
PET scan using 68Ga-DOTATATE contrast
- Number of participants for whom the intended clinical management prior to PET is changed after 68Ga-DOTATATE PET. [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873870
|Contact: Ur Metser, M.D.||416-946-4501 ext firstname.lastname@example.org|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Ur Metser, M.D. 416-946-4501 ext 4394 email@example.com|
|Principal Investigator:||Ur Metser, M.D.||Princess Margaret Cancer Centre|