A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors
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|ClinicalTrials.gov Identifier: NCT03057509|
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : October 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Small Bowel Carcinoid Tumor||Drug: Ga-68-DOTA-TOC Device: Siemens PET/MR scanner Other: Standard Siemens Software Drug: LAR Octreotide||Phase 1|
This research study is a Pilot Study, which is the first time investigators are examining this study intervention.
Many patients who are diagnosed with carcinoid tumor undergo treatment with long acting release (LAR) octreotide. It is presently standard for all patients to receive equal doses of octreotide. However, the response to the treatment with the same dose of medication may vary substantially from one person to another. This study uses a novel form of PET/MR imaging to try and better understand how to treat carcinoid tumors, and may in the future allow doctors to tailor treatment dosing based on PET/MR findings and select the right drug dose for an individual person. It is important to note that the participant method of treatment and the dose of the participant medication (Octreotide LAR) will not change in this study.
The imaging technique used in this study is called Ga-68-DOTA-TOC PET/MR scanning. Ga-68-DOTA-TOC is a radioactive tracer that is given by vein to participants before PET scanning. The scanner then detects radioactivity from the tracer that is attached to cells within the body and uses this information to create images (pictures) on a computer screen that can then be analyzed.
These types of scans are investigational. "Investigational", meaning that the scans are still being studied and that research doctors are trying to find out more about them. It also means that the FDA (U.S. Food and Drug Administration) has not approved these types of PET scans for this type of cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: Gallium PET/MR Imaging
Siemens PET/MR scanner at Martinos Center for Biomedical Imaging will be use.
Ga-68-DOTA-TOC is a imaging radiotracer that is used for positron emission tomography imaging of a variety of the neuroendocrine tumors. This radiotracer in the body binds to several subtypes of the somatostatin receptor and accumulates in the tissue with high expression of these receptors. Therefore neuroendocrine tumors that express somatostatin receptors can be imaged using this radiotracer.
Device: Siemens PET/MR scanner
Positron emission tomography-magnetic resonance (PET/MR) is a hybrid imaging technology that incorporates magnetic resonance imaging (MRI) soft tissue morphological imaging and positron emission tomography (PET) functional imaging. The Siemens PET/MR system (Biograph mMR) received a CE mark and FDA approval for clinical diagnostic imaging.
Other: Standard Siemens Software
The Siemens PET/MR scanner are equipped with a standard clinical visualization software with the advanced application tools based on the Siemens image interpretation engine called syngo.via. This software allows for visualization and interpretation of the image data-sets in the clinical environment.
Drug: LAR Octreotide
LAR octreotide is a man-made protein that is similar to a hormone in the body called somatostatin. LAR Octreotide lowers many substances in the body such as insulin and glucagon, growth hormone, and chemicals that affect digestion. LAR octreotide is used to treat a variety of clinical conditions but most importantly to reduce flushing episodes and watery diarrhea caused by cancerous tumors such as neuroendocrine tumors.
Other Name: Sandostatin
- Mean Change in SUVmax [ Time Frame: 2 years ]The mean change of SUVmax from 68Ga-DOTATOC PET scan obtained at peak and trough octreotide LAR therapy.
- Mean Change in Total Molecular Burden of The Lesions [ Time Frame: 2 Years ]The mean change of Total Molecular Tumor Burden is measured from 68Ga-DOTATOC PET scan obtained at peak and trough octreotide LAR therapy.
- Correlation Of Change In Receptor Occupancy With The PFS of patients [ Time Frame: 2 years ]
- Progression Free Survival Rate [ Time Frame: 2 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): NCT03057509
|Contact: Umar Mahmood, MD, PhDemail@example.com|
|United States, Massachusetts|
|Massachusetts general Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Umar Mahmood, MD, PhD 617-726-6477 firstname.lastname@example.org|
|Principal Investigator: Umar mahmood, MD, PhD|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Matthew Kulke, MD 617-632-5136 Mathew_kulke@dfci.harvard.edu|
|Principal Investigator: Matthew Kulke, MD|
|Principal Investigator:||Umar Mahmood, MD, PhD||Massachusetts General Hospital|