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| Name | Class |
|---|---|
| University of Iowa | OTHER |
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Participants in this study have been diagnosed with a tumor such as a carcinoid, neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which carry somatostatin receptors.
The purpose of this research study is to see if the tumor can be identified using a special procedure called a positron emission tomography (PET) scan and how the results of this imaging procedure will change the management of the tumor.
This is a prospective, Phase II, single center, open-label study in a total of 200 participants with histologically proven neuroendocrine tumor or other somatostatin receptor positive tumors. Eligible participants will undergo baseline assessments at enrollment. They will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Participants may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-DOTATOC PET/CT | Other | Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-DOTATOC PET/CT | Drug | Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Change in Treatment Management Based on Findings of the Gallium Ga 68-edotreotide PET/CT Scan | Referring physicians will be asked to fill out pre-PET and post-PET scan forms to provide information on the management and treatment strategy of the patient before the PET-CT scan and after the information from the PET-CT study is available. This is the same methodology used in the National Oncologic PET Registry study; change in management strategy criteria are modified for the specific treatment strategies used in NET. | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary S O'Dorisio, MD, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23587853 | Background | Menda Y, Ponto LL, Schultz MK, Zamba GK, Watkins GL, Bushnell DL, Madsen MT, Sunderland JJ, Graham MM, O'Dorisio TM, O'Dorisio MS. Repeatability of gallium-68 DOTATOC positron emission tomographic imaging in neuroendocrine tumors. Pancreas. 2013 Aug;42(6):937-43. doi: 10.1097/MPA.0b013e318287ce21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 68Ga-DOTATOC PET/CT | Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan. 68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 68Ga-DOTATOC PET/CT | Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan. 68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Change in Treatment Management Based on Findings of the Gallium Ga 68-edotreotide PET/CT Scan | Referring physicians will be asked to fill out pre-PET and post-PET scan forms to provide information on the management and treatment strategy of the patient before the PET-CT scan and after the information from the PET-CT study is available. This is the same methodology used in the National Oncologic PET Registry study; change in management strategy criteria are modified for the specific treatment strategies used in NET. | Study stopped early, 114 of the 122 patients enrolled were analyzed for outcome measure | Posted | Count of Participants | Participants | 36 months |
|
Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 68Ga-DOTATOC PET/CT | Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan. 68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M.Sue O'Dorisio | University of Iowa, Holden Comprehensive Cancer Center | (319) 335-7234 | sue-odorisio@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 14, 2018 | Mar 11, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2016 | Nov 19, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D002276 | Carcinoid Tumor |
| D009447 | Neuroblastoma |
| D008527 | Medulloblastoma |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 2 |
| 122 |
| 0 |
| 122 |
| 42 |
| 122 |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D009380 | Neoplasms, Nerve Tissue |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D005910 | Glioma |