A Phase 2 interventional study of 68Gallium DOTATATE and Radio-guided surgery in Neuroendocrine Tumors, Von Hippel-Lindau Syndrome and Hippel-Lindau Disease, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 10 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Diagnostic
Background:
Objectives:
Eligibility:
Design:
Background:
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:
Design:
676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.
This study's enrollment of 341 is above the median of 42 across 464 interventional studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with (any one of #1, #2, and/or #3):
EXCLUSION CRITERIA:
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.
68Gallium DOTATATE imaging
Drug: 68Gallium DOTATATE · Procedure: Radio-guided surgery
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.
Using 68Gallium DOTATATE
Number of Lesions Detected Using the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) Scan
Patients with neuroendocrine tumors (NETs) were scanned with the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) and the number of lesions detected are collected.
Time frame: During PET Scan, up to 2 hours annually for up to 5 years
Mean Radiation Activity Between Low Grade and Intermediate Grade Neuroendocrine Tumor
The radioactivity was assessed using intraoperative radiation detector following the 68Gallium-DOTATATE injection. Low grade neuroendocrine tumors is defined as tumors with slow cell division determined in histology. Low grade tumors is associated with the best outcome. Intermediate grade tumor is defined as the tumor with medium (3-20%) rate of actively dividing cells and is associated with less favorably outcome.
Time frame: During radioguided surgery, up to 2 hours
Tumor Volume of Neuroendocrine Tumors Assessed by the 68Gallium-DOTATATE Scan
Participants were scanned using the 68Gallium-DOTATATE Scan. Tumor volume more than 7ml is associated with shorter time to disease progression. Tumor volume more than 36 ml is associated with shorter disease specific survival.
Time frame: During radioguided surgery, up to 2 hours
Median Radioactivity of Tumors With High Expression of Somatostatin Receptor 2 Compared to Tumors With Intermediate Expression of Somatostatin Receptor 2
High expression of somatostatin receptor 2 (SSTR2) is based on the intensity grading on immunohistochemistry. High SSTR2 expression may be associated with well-differentiated tumor and high avidity on DOTATATE scan, compared to intermediate or low expression of SSTR that can be seen in poorly differentiated and often aggressive neuroendocrine tumors. Because the correlation can only be from the comparison of preoperative DOTATATE and the tumors that were removed, it is a one time analysis. Subsequent DOTATATE studies are for surveillance and follow up for disease progression or recurrence.
Time frame: During PET Scan, up to 2 hours annually
The Number of Tumors Identified in Participants by the Radiation Detector During Radio-guided Surgery Using 68Gallium-DOTATATE
Radio-guided surgery in neuroendocrine tumors using 68Gallium-DOTATATE was performed to detect tumors in the stomach and small bowel neuroendocrine tumors, pancreas, metastatic sites to lymph nodes and liver, and pheochromocytoma or paraganglioma. The number of tumors identified by the radiation detector were assessed.
Time frame: Radio-guided surgery, up to 2 hours
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Date treatment consent signed to date off study, approximately 50 months and 17 days.
| Milestone | 68Gallium DOTATATE Imaging |
|---|---|
| Started | 341 |
| Completed | 281 |
| Not completed | 60 |
| Withdrew: Withdrawal by subject | 52 |
| Withdrew: Refuse treatment | 2 |
| Withdrew: Lost to follow-up | 6 |
Patients with neuroendocrine tumors (NETs) were scanned with the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) and the number of lesions detected are collected.
| Number of lesions | 68Gallium DOTATATE Imaging |
|---|---|
| Number of Lesions Detected Using the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) Scan | 847 |
The radioactivity was assessed using intraoperative radiation detector following the 68Gallium-DOTATATE injection. Low grade neuroendocrine tumors is defined as tumors with slow cell division determined in histology. Low grade tumors is associated with the best outcome. Intermediate grade tumor is defined as the tumor with medium (3-20%) rate of actively dividing cells and is associated with less favorably outcome.
| 511KeV count per ten seconds | 68Gallium DOTATATE Imaging |
|---|---|
| Low grade | 504.9 ± 534 |
| Intermediate grade | 205 ± 147 |
Participants were scanned using the 68Gallium-DOTATATE Scan. Tumor volume more than 7ml is associated with shorter time to disease progression. Tumor volume more than 36 ml is associated with shorter disease specific survival.
| ml | 68Gallium DOTATATE Imaging |
|---|---|
| Tumor Volume of Neuroendocrine Tumors Assessed by the 68Gallium-DOTATATE Scan | 9.24 (0.06 to 1136.7) |
High expression of somatostatin receptor 2 (SSTR2) is based on the intensity grading on immunohistochemistry. High SSTR2 expression may be associated with well-differentiated tumor and high avidity on DOTATATE scan, compared to intermediate or low expression of SSTR that can be seen in poorly differentiated and often aggressive neuroendocrine tumors. Because the correlation can only be from the comparison of preoperative DOTATATE and the tumors that were removed, it is a one time analysis. Subsequent DOTATATE studies are for surveillance and follow up for disease progression or recurrence.
| Tumor to background ratio | 68Gallium DOTATATE Imaging |
|---|---|
| High expression | 6.5 (3.4 to 14.9) |
| Low expression | 3.7 (3.5 to 6.3) |
Radio-guided surgery in neuroendocrine tumors using 68Gallium-DOTATATE was performed to detect tumors in the stomach and small bowel neuroendocrine tumors, pancreas, metastatic sites to lymph nodes and liver, and pheochromocytoma or paraganglioma. The number of tumors identified by the radiation detector were assessed.
| Number of tumors | 68Gallium DOTATATE Imaging |
|---|---|
| Stomach and small bowel | 23 |
| Pancreas tumors | 24 |
| Pheochromocytoma and paraganglioma | 6 |
| Liver metastasis | 9 |
| Metastatic lymph nodes | 71 |
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
| Participants | 68Gallium DOTATATE Imaging |
|---|---|
| Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | 21 |
Collected over Date treatment consent signed to date off study, approximately 50 months and 17 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 68Gallium DOTATATE Imaging | 16/341 (4.7%) | 20/341 (5.9%) | 1/341 (0.3%) |
| Event | 68Gallium DOTATATE Imaging |
|---|---|
| Death (unrelated to 68 Gallium DOTATATE)General disorders | 16/341 |
| Thromboembolic eventVascular disorders | 3/341 |
| HyperglycemiaMetabolism and nutrition disorders | 1/341 |
| Event | 68Gallium DOTATATE Imaging |
|---|---|
| Alteration of consciousnessNervous system disorders | 1/341 |
| Age, Categorical(Participants) | 68Gallium DOTATATE Imaging |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 238 |
| >=65 years | 102 |
| Age, Continuous(years) | 68Gallium DOTATATE Imaging |
|---|---|
| Mean | 55.89 ± 14.43 |
| Sex: Female, Male(Participants) | 68Gallium DOTATATE Imaging |
|---|---|
| Female | 194 |
| Male | 147 |
| Race/Ethnicity, Customized(Participants) | 68Gallium DOTATATE Imaging |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 9 |
| Black or African American | 24 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Other | 7 |
| Race Unknown | 9 |
| White | 290 |
| Hispanic or Latino | 17 |
| Not Hispanic or Latino | 323 |
| Ethnicity Unknown | 1 |
| Region of Enrollment(Participants) | 68Gallium DOTATATE Imaging |
|---|---|
| United States | 341 |
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National Cancer Institute (NCI)