Carcinoid TumorsNCT01980732
68Ga DOTA-TATE PET/CT in Somatostatin Receptor Positive Tumors
A study testing 68Ga-DOTA TATE in people with Carcinoid Tumors and Islet Cell (Pancreatic NET), run by Andrei Iagaru at 1 site in United States.
Trial summary
The primary objective of the study is to evaluate 68Ga-DOTA TATE PET/CT for staging and monitoring response to chemotherapy in patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid Tumors, Islet Cell (Pancreatic NET), Other Neuroendocrine Tumors
- What is being tested?
- 68Ga-DOTA TATE
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 18 years-old at the time of radiotracer administration
- Provides written informed consent
- Known diagnosis of NET or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen when clinically indicated
- Karnofsky score greater than 50 or ECOG Performance Status 0-2
- Women of childbearing age must have a negative pregnancy test at screening/baseline
- Able to remain still for duration of each imaging procedure (about one hour)
Who cannot join
- Less than 18 years-old at the time of radiotracer administration
- Pregnant or nursing
- Serum creatinine >3.0 mg/dL
- Hepatic enzyme levels more than 5 times upper limit of normal.
- Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
- Inability to lie still for the entire imaging time
- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Stanford, California, 94305
About this study
Official title: 68Ga DOTA-TATE PET/CT in the Evaluation of Patients With Somatostatin Receptor Positive Tumors
The primary objective of the study is to evaluate 68Ga-DOTA TATE PET/CT for staging and monitoring response to chemotherapy in patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.
- Being tested
- 68Ga-DOTA TATE
- Medical subject headings
- Carcinoid Tumor, Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTA TATEDrug
Patients with somatostatin receptor positive tumors will be evaluated with 68Ga-DOTA TATE PET/CT in addition to conventional imaging.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Andrei Iagaru
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrei Iagaru, Stanford University
- Investigators
- Andrei Iagaru, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980732
- Sponsor's protocol ID
- NET0017
- Other IDs
- 26988
- Status last verified
- Aug 2017
- First submitted
- 4 Nov 2013
- Last updated
- 23 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga DOTA-TATE PET/CT in the Evaluation of Patients With Somatostatin Receptor Positive Tumors
- ClinicalTrials.gov ID
- NCT01980732
- Acronym / sponsor ID
- NET0017
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Andrei IagaruUniversity, hospital or other
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate 68Ga-DOTA TATE PET/CT for staging and monitoring response to chemotherapy in patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Greater than 18 years-old at the time of radiotracer administration
- Provides written informed consent
- Known diagnosis of NET or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen when clinically indicated
- Karnofsky score greater than 50 or ECOG Performance Status 0-2
- Women of childbearing age must have a negative pregnancy test at screening/baseline
Key exclusion criteria (8 listed)
- Less than 18 years-old at the time of radiotracer administration
- Pregnant or nursing
- Serum creatinine >3.0 mg/dL
- Hepatic enzyme levels more than 5 times upper limit of normal.
- Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-DOTA TATEPatients with somatostatin receptor positive tumors will be evaluated with 68Ga-DOTA TATE PET/CT in addition to conventional imaging. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
Related trials for Carcinoid Tumors
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Natural History of Familial Carcinoid Tumor
Carcinoid
RecruitingObservational study
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Esophageal Cancer, Head and Neck Cancer
RecruitingPhase 1
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Iagaru principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-DOTA TATE in people with Carcinoid Tumors and Islet Cell (Pancreatic NET), run by Andrei Iagaru at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.