Neuroendocrine Tumors
Conditions
Brief summary
The primary goal of the analysis is to estimate the diagnostic accuracy of Gallium 68 (68Ga) -DOTATOC PET/CT for detecting neuroendocrine tumors (NETs) compared to conventional imaging techniques such as Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT). Participants with histologically and/or clinically confirmed and/or suspected NET will be enrolled.
Detailed description
This is a prospective, Phase 2, single center study of participants with Neuroendocrine Tumors (NETs). Study participants will receive 68Ga-DOTATOC. DOTATOC is a somatostatin analogue that localizes on the somatostatin receptors expressed by NETs and is attached to a radioactive material called Gallium 68. Participants will undergo a PET/CT imaging study to investigate 68Ga-DOTATOC's suitability as a positron emission tomography (PET) imaging agent for NETs. The radiation (imaging) dose will be 111-185 megabecquerel (MBq) (3 - 5 mCi) ± 25%. All doses after labeling will be presented in buffered solution for intravenous injection. Imaging will start 90 ±30 minutes after injection. Sensitivity and specificity of this imaging technique will be compared with those of conventional imaging modality including CT, MRI and In-111 Octreoscan performed within 6-12 months before or after PET/CT.
Interventions
DRUG68Ga-DOTATOC
The intervention is to administer 68Ga-DOTATOC PET/CT for detecting NET.
Sponsors
NCM USA
Montefiore Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent. * Patients of either gender, aged ≥18 years. * Karnofsky status ≥60. * Life expectancy of at least 12 weeks. * Histologically and/or clinically confirmed and/or suspicious of NET. * A diagnostic CT or MRI of the tumour region or suspected area within the previous 12 weeks prior to dosing day is available. * Somatostatin-analogue scintigraphy scan with result (positive or negative) within the last 12 weeks. * Recent Blood test results up to 4-6 weeks as follows: 1. White Blood Cell (WBC): \>2\*109/L 2. Haemoglobin: \>8.0g/Dl 3. Platelets: \>50x109/L 4. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline phosphatase (AP) each less than, or equal to, 5 times its Upper Limit of Normal (ULN) 5. Bilirubin less than, or equal to, three times its ULN * Serum creatinine: within normal range or \<120μmol/L for patients aged 60 years or older. * Negative pregnancy test in women capable of child-bearing.
Exclusion criteria
* Known hypersensitivity to Gallium 68, DOTATOC or to any of the excipients of 68Ga-DOTATOC. * Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (Long Acting Release) (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug. * Pregnant or breast-feeding women. * Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity to Correctly Diagnose NET | During imaging process ( approximately 120 minutes) | Sensitivity to detect NET will be assessed and compared with conventional imaging modality. Sensitivity is the ability of an agent to indicate the presence and location of NET. The ability of 68Ga-DOTATOC to localize more effectively to somatostatin receptors and the exquisite spatial resolution of PET/CT should make easier detection of primary and metastatic neuroendocrine tumors and allow better measurement of tumor burden. Sensitivity is the percentage of accurately diagnosed NET cases. All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) as standard care prior to 68Ga-DOTATOC imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity to Detect True Negative | During imaging process ( approximately 120 minutes) | A tumor is an abnormal growth of cells which can be malignant or not. NET tumors secrete hormones that will disrupt the normal ecology of the body. 68Ga-DOTATOC is extremely sensitive and specific to the receptors expressed by NET. These attributes are unique to 68Ga-DOTATOC and makes it the only imagining technique that can determine whether or not lesions detected by conventional imaging is due to NET involvement. 68Ga-DOTATOC is able to exclude disease involvement in lesions detected on CT/MRI; this ability to exclude disease involvement is called Specificity. The reported values indicate the specificity of 68Ga-DOTATOC, which is the percentage of tumors detected by conventional imagining that 68Ga-DOTATOC correctly determined were not due to NET involvement (i.e. identifying true negative for NET). |
Participant flow
Recruitment details
Participants were recruited at Montefiore Medical Center which has medical specializing in the diagnosis and treatment of NETs. Eligible participants were those referred by their physicians for PET (Positron Emission Tomography) or CT imaging due to suspected or confirmed NETs.
Participants by arm
| Arm | Count |
|---|---|
| 68Ga-DOTATOC PET/CT Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study to measure its ability to detect primary NET and any metastasis. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | 68Ga-DOTATOC PET/CT | — |
|---|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 8.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 11 Participants | — |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Sensitivity to Correctly Diagnose NET
Sensitivity to detect NET will be assessed and compared with conventional imaging modality. Sensitivity is the ability of an agent to indicate the presence and location of NET. The ability of 68Ga-DOTATOC to localize more effectively to somatostatin receptors and the exquisite spatial resolution of PET/CT should make easier detection of primary and metastatic neuroendocrine tumors and allow better measurement of tumor burden. Sensitivity is the percentage of accurately diagnosed NET cases. All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) as standard care prior to 68Ga-DOTATOC imaging.
Time frame: During imaging process ( approximately 120 minutes)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 68Ga-DOTATOC PET/CT | Sensitivity to Correctly Diagnose NET | Liver metastases | 100 percent of NET correctly diagnosed |
| 68Ga-DOTATOC PET/CT | Sensitivity to Correctly Diagnose NET | Lymph node metastasis | 100 percent of NET correctly diagnosed |
| 68Ga-DOTATOC PET/CT | Sensitivity to Correctly Diagnose NET | Bone metastasis | 100 percent of NET correctly diagnosed |
| 68Ga-DOTATOC PET/CT | Sensitivity to Correctly Diagnose NET | Primary lesions | 75 percent of NET correctly diagnosed |
| Conventional Imaging | Sensitivity to Correctly Diagnose NET | Bone metastasis | 50 percent of NET correctly diagnosed |
| Conventional Imaging | Sensitivity to Correctly Diagnose NET | Liver metastases | 75 percent of NET correctly diagnosed |
| Conventional Imaging | Sensitivity to Correctly Diagnose NET | Primary lesions | 75 percent of NET correctly diagnosed |
| Conventional Imaging | Sensitivity to Correctly Diagnose NET | Lymph node metastasis | 40 percent of NET correctly diagnosed |
Secondary
Specificity to Detect True Negative
A tumor is an abnormal growth of cells which can be malignant or not. NET tumors secrete hormones that will disrupt the normal ecology of the body. 68Ga-DOTATOC is extremely sensitive and specific to the receptors expressed by NET. These attributes are unique to 68Ga-DOTATOC and makes it the only imagining technique that can determine whether or not lesions detected by conventional imaging is due to NET involvement. 68Ga-DOTATOC is able to exclude disease involvement in lesions detected on CT/MRI; this ability to exclude disease involvement is called Specificity. The reported values indicate the specificity of 68Ga-DOTATOC, which is the percentage of tumors detected by conventional imagining that 68Ga-DOTATOC correctly determined were not due to NET involvement (i.e. identifying true negative for NET).
Time frame: During imaging process ( approximately 120 minutes)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 68Ga-DOTATOC PET/CT | Specificity to Detect True Negative | Primary lesions | 100 percent of tumors identified as non-NET |
| 68Ga-DOTATOC PET/CT | Specificity to Detect True Negative | Liver metastases | 100 percent of tumors identified as non-NET |