Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Other Indications, Brain Cancer |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 10 - 99 |
| Updated: | 4/4/2019 |
| Start Date: | October 18, 2013 |
| End Date: | December 3, 2022 |
Evaluation of (68)Gallium- DOTATATE PET/CT for Detecting Primary and Metastatic Neuroendocrine Tumors
Background:
- 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.
Objectives:
- To see how well a new experimental imaging agent, 68Gallium-DOTATATE, detects unknown
primary and metastatic NETs in the gastrointestinal system and pancreas.
Eligibility:
- Adults over 10 years old with a suspected NET or family history of NET.
Design:
- 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.
- A standard computed tomography (CT) scan of the chest, abdomen, and pelvis.
- An octreotide scintigraphy Single photon emission computed tomography (SPECT)/CT.
- A 68Gallium-DOTATATE positron emission tomography (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.
- 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.
Objectives:
- To see how well a new experimental imaging agent, 68Gallium-DOTATATE, detects unknown
primary and metastatic NETs in the gastrointestinal system and pancreas.
Eligibility:
- Adults over 10 years old with a suspected NET or family history of NET.
Design:
- 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.
- A standard computed tomography (CT) scan of the chest, abdomen, and pelvis.
- An octreotide scintigraphy Single photon emission computed tomography (SPECT)/CT.
- A 68Gallium-DOTATATE positron emission tomography (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.
Background:
- 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.
Objectives:
-To determine the accuracy of 68Gallium-DOTATATE PET/CT scans in detecting unknown primary
and metastatic gastrointestinal and pancreatic neuroendocrine tumors.
Eligibility:
- Patients with:
- suspicion of NET on axial imaging (CT/magnetic resonance imaging
(MRI)/fluorodeoxyglucose-positron emission tomography (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 multiple endocrine neoplasia type 1
(MEN1) and VHL.
- Age greater than or equal to 18 years of age.
- Patients must be willing to return to National Institutes of Health (NIH) for follow-up.
Design:
- 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
Von Hippel-Lindau (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.
- 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.
Objectives:
-To determine the accuracy of 68Gallium-DOTATATE PET/CT scans in detecting unknown primary
and metastatic gastrointestinal and pancreatic neuroendocrine tumors.
Eligibility:
- Patients with:
- suspicion of NET on axial imaging (CT/magnetic resonance imaging
(MRI)/fluorodeoxyglucose-positron emission tomography (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 multiple endocrine neoplasia type 1
(MEN1) and VHL.
- Age greater than or equal to 18 years of age.
- Patients must be willing to return to National Institutes of Health (NIH) for follow-up.
Design:
- 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
Von Hippel-Lindau (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.
- INCLUSION CRITERIA:
- Patients with (any one of #1, #2, and/or #3):
1. Suspicion of neuroendocrine tumors (NET) on axial imaging (computed tomography
(CT)/magnetic resonance imaging (MRI)/fluorodeoxyglucose (FDG) positron emission
tomography (PET) and/or
2. biochemical evidence of neuroendocrine tumor (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
3. familial predisposition to NET in patients with multiple endocrine neoplasia type
1 (MEN1) and Von Hippel-Lindau (VHL) (symptomatic and/or asymptomatic cases; with
biochemical or anatomic imaging evidence of disease).
- Age greater than or equal to 10 years of age.
- For females: Negative urine pregnancy test OR post-menopausal for at least 2 years OR
patient has had a hysterectomy.
- Patients must be willing to return to National Institutes of Health (NIH) for
follow-up.
- Ability of subject or Legally Authorized Representative (LAR) (if the patient is
deemed by the treating physician to be cognitively impaired or questionably impaired
in such a way that the ability of the patient to give informed consent is
questionable) to understand and the willingness to sign a written informed consent
document indicating that they are aware of the investigational nature of this study.
EXCLUSION CRITERIA:
- Patients unwilling to undergo serial non-invasive imaging.
- Pregnant or lactating women: Pregnant women are excluded from this study because the
effects of (68)Ga-DOTATATE in pregnancy are not known. Because there is an unknown but
potential risk for adverse events in nursing infants secondary to administration of
(68)Ga-DOTATATE in the mother, breastfeeding should be discontinued for at least one
day if the mother receives (68)Ga-DOTATATE.
- Patients that have recognized concurrent active infection,
- Patients with the use of any investigational product or device, excluding
18F-dihydroxyphenylalanine (F-DOPA) scans, within 30 days prior to dosing.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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