Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT01967537|
Recruitment Status : Active, not recruiting
First Posted : October 23, 2013
Last Update Posted : February 14, 2018
- Neuroendocrine tumors (NETs) are rare but have been more common over the past decade. The only treatment for NETs is surgery, but most are found when they are too advanced for surgery. Researchers are looking for the best way to find NETs earlier, so that surgery can be successful. They want to test if the study drug can be used along with imaging devices to detect NETs.
- To see how well a new experimental imaging agent, 68Gallium-DOTATATE, detects unknown primary and metastatic NETs in the gastrointestinal system and pancreas.
- Adults over 10 years old with a suspected NET or family history of NET.
- Participants will be screened with a medical history and physical exam, and have a blood test.
- Participants will undergo three scans. For all of these, a substance is injected into their body, they lie on a table, and a machine takes images.
<TAB>- A standard CT scan of the chest, abdomen, and pelvis.
<TAB>- An octreotide scintigraphy SPECT/CT.
<TAB>- A 68Gallium-DOTATATE PET/CT. The study drug is injected into a vein, usually in the arm. Low-dose X-rays go through the body. For about 40 minutes a large, donut-shaped device takes images of the body. The entire session takes 90 to 120 minutes.
- Researchers will compare images from the three scans.
- Participants will have 1 follow-up visit each year for 5 years. At this visit, they will have a medical exam, blood taken, and a CT scan.
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors Von Hippel-Lindau Syndrome Hippel-Lindau Disease||Drug: 68Gallium DOTATATE Procedure: Radio-guided surgery||Phase 2|
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- Neuroendocrine tumors (NETs) are rare malignancies occurring in the gastrointestinal tract, islets of the pancreas, lung, adrenal medulla and thyroid C-cells.
- Their incidence has increased over the last decade, with an incidence of 6 per 100,000 persons a year and they represent 0.46% of all malignancies.
- Most NETs are sporadic, but they can be part of familial cancer syndromes such as multiple endocrine neoplasia type 1 (MEN1), MEN2, and neurofibromatosis type 1 (NF1) or Von Hippel-Lindau (VHL) syndrome.
- Surgical resection remains the only curative treatment option for patients with NETs but 80% of patients are diagnosed with advanced (metastatic, locally inoperable, or recurrent) disease.
- The main prognostic factor in patients with NET is the extent of disease.
- The best imaging technique for detecting unknown primary and metastatic NETs has yet to be determined.
- NET cells express somatostatin receptors that can be targeted with radiolabeled 68Gallium-DOTATATE (Octreotate) for imaging purposes.
- The primary goal of this protocol is to determine the accuracy of a new somatostatin receptor targeted imaging technique, using 68Gallium-DOTATATE PET/CT to detect unknown primary and metastatic NETs.
-To determine the accuracy of 68Gallium-DOTATATE PET/CT scans in detecting unknown primary and metastatic gastrointestinal and pancreatic neuroendocrine tumors.
- suspicion of NET on axial imaging (CT/MRI/FDG PET) and/or
- biochemical evidence of NET (serum/urinary) based on elevated levels of chromogranin A, pancreatic polypeptide, neuron-specific enolase, vasoactive intestinal polypeptide, serotonin (urinary 5-HIAA), gastrin, somatostatin, catecholamines, metanephrines, calcitonin, fasting insulin, C-peptide (proinsulin), glucagon and/or
- familial predisposition to NET in patients with MEN1 and VHL.
- Age greater than or equal to 18 years of age.
- Patients must be willing to return to NIH for follow-up.
- Prospective study.
- A 68Ga-DOTATATE PET/CT scan will be done in patients with suspicious lesions, unknown primary tumor or metastatic gastrointestinal or pancreatic neuroendocrine disease found on anatomic imaging (CT/MRI) or in patients having biochemically active disease.
- Both functional and non-functional solid tumors will be included in this study. Furthermore, asymptomatic and symptomatic, sporadic and familial cases of NETs (such as VHL, MEN1) will be included.
- Demographic, clinical and pathologic data will be collected from the medical record and patient interview for each patient. Data will be stored in a computerized database.
- After their initial on-study evaluation, patients will be staged according to findings on imaging studies with respect to primary tumor site, size and metastases. Surgical resection of NET and/or medical managements will be recommended based on standard practice guidelines. In patients who undergo surgical treatment, the samples will be immediately stored until molecular analysis.
- Follow up will be done yearly for a total duration of 5 years. This includes a yearly imaging study and a biochemical and clinical evaluation, to assess tumor growth and disease progression.
- We estimate that the accrual rate will be 3-10 patients per month; the total accrual period for this study will be 10 months to 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||337 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of (68)Gallium- DOTATATE PET/CT for Detecting Primary and Metastatic Neuroendocrine Tumors|
|Study Start Date :||October 18, 2013|
|Actual Primary Completion Date :||December 17, 2017|
|Estimated Study Completion Date :||December 3, 2022|
68Gallium DOTATATE imaging
Drug: 68Gallium DOTATATE
Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.
Procedure: Radio-guided surgery
Using 68Gallium DOTATATE
- To determine the accuracy of 68Gallium-DOTATATE PET/CT scans in detecting unknown primary and metastatic gastrointestinal and pancreatic neuroendocrine tumors [ Time Frame: 5 years ]To assess the diagnostic accuracy of the new imaging technique (68)Gallium-DOTATATE PET/CT scan for patients with NETs
- To evaluate 68Gallium-DOTATATE uptake in NETs and its association with tumor differentiation. [ Time Frame: Five years ]Correlation between 68Gallium- DOTATATE uptake in NETs and tumor differentiation
- To determine whether 68Gallium-DOTATATE uptake value is predictive of tumor growth and/or disease progression. [ Time Frame: Five years ]Correlation between 68Gallium-DOTATATE uptake and tumor growth and/or disease progression
- To determine the relation between somatostatin receptor status in tumor samples and 68Gallium- DOTATATE uptake. [ Time Frame: Five years ]Correlation between somatostatin receptor status in tumor samples and 68Gallium-DOTATATE uptake
- To evaluate the feasibility of radioguided surgery in NETs using 68Gallium-DOTATATE. [ Time Frame: Five years ]Feasibility of radio-guided surgery in NETs using 68Gallium-DOTATATE
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): NCT01967537
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Electron Kebebew, M.D.||National Cancer Institute (NCI)|