Neuroendocrine TumorsNCT03288597
Explore the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms
An observational study of Neuroendocrine Tumors, run by Peking University at 1 site in China.
Trial summary
68Ga-DOTANOC and 18F-FDG PET/CT have important values in the staging and clinical treatment of neuroendocrine tumors. Retrospective studies suggest that the positivite rates and SUVmax of dual imaging associated with pathological findings and prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NET and 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NEC
- Type of treatment
- Surgery or procedure
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 1 Sep 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: Neuroendocrine neoplasmes
Who may be able to join
- sign written informed consent form
- age ≥ 18 years
- pathologically confirmed neuroendocrine, Ki67>=10%;
- ECOG 0-1;
- No prior antitumor treatment with chemotherapy targeting regimens for neuroendocrine carcimomas, no more than 2 systematic treatment for neuroendocrine tumors;
- Unresectable disease;
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- At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions);
- Predicted survival >=3 months;
- Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women;
- Sexually active males or females willing to practice contraception during the study until 30 days after end of study.
Who cannot join
- In the process of antitumor therapy with effective response;
- Refuse to accept PET/CT;
- Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;
- Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons；
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Shen Lin, Professor, 010-88196561, Linshenpku@163.com
Shen Lin, professor
About this study
Official title: A Prospective Exploration in the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms
68Ga-DOTANOC and 18F-FDG PET/CT have important values in the staging and clinical treatment of neuroendocrine tumors. Retrospective studies suggest that the positivite rates and SUVmax of dual imaging associated with pathological findings and prognosis. The study was designed to confirm thet clinical values of dual imagings for neuroendocrine tumors.
- Conditions
- Neuroendocrine Tumors
- Being tested
- 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NET, 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NEC
- Keywords
- positive rate, SUVmax, relationship
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NETRadiation
At the beginning of the treatment with SSA, after 6 months, 12 months, or chemotherapy, after 3 months or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT
68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NECRadiation
At the beginning of the treatment with chemotherapy 4-6 cycles or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT
| Study group | Role | What they receive |
|---|---|---|
| A: advanced and metastatic neuroendocrine tumors | Advanced and metastatic neuroendocrine tumors receive syestematic treatment Receives: Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NET | |
| A: advanced and metastatic neuroendocrine carcinomas | Advanced and metastatic neuroendocrine carcinomas receive syestematic treatment Receives: Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between the positive rate and SUVs of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT and treatment response
Measured: 3 years
Secondary outcomes (2)
The correlation between positive rate and SUV of PET/CT and prognosis
Measured: 3 year
Compare SUVmax, tumor/liver ratio as a prognostic marker
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288597
- Sponsor's protocol ID
- 68Ga&FDG PET/CT
- Status last verified
- Sep 2017
- First submitted
- 16 Sep 2017
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Exploration in the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms
- ClinicalTrials.gov ID
- NCT03288597
- Acronym / sponsor ID
- 68Ga&FDG PET/CT
- Conditions
- Neuroendocrine Tumors
- Keywords
- positive rate, SUVmax, relationship
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 20 Sep 2017 (actual)
- 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.
68Ga-DOTANOC and 18F-FDG PET/CT have important values in the staging and clinical treatment of neuroendocrine tumors. Retrospective studies suggest that the positivite rates and SUVmax of dual imaging associated with pathological findings and prognosis. The study was designed to confirm thet clinical values of dual imagings for neuroendocrine tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: advanced and metastatic neuroendocrine tumors | – | Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NETAdvanced and metastatic neuroendocrine tumors receive syestematic treatment |
| A: advanced and metastatic neuroendocrine carcinomas | – | Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NECAdvanced and metastatic neuroendocrine carcinomas receive syestematic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neuroendocrine neoplasmes
Key inclusion criteria (10 listed)
- sign written informed consent form
- age ≥ 18 years
- pathologically confirmed neuroendocrine, Ki67>=10%;
- ECOG 0-1;
- No prior antitumor treatment with chemotherapy targeting regimens for neuroendocrine carcimomas, no more than 2 systematic treatment for neuroendocrine tumors;
Key exclusion criteria (4 listed)
- In the process of antitumor therapy with effective response;
- Refuse to accept PET/CT;
- Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;
- Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons；
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-DOTANOC PET/CT and 18F-FDG PET/CT in NETAt the beginning of the treatment with SSA, after 6 months, 12 months, or chemotherapy, after 3 months or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT | Radiation | A: advanced and metastatic neuroendocrine tumors |
| 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NECAt the beginning of the treatment with chemotherapy 4-6 cycles or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT | Radiation | A: advanced and metastatic neuroendocrine carcinomas |
Primary outcome
The correlation between the positive rate and SUVs of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT and treatment response
Time frame: 3 years
2 secondary outcomes
The correlation between positive rate and SUV of PET/CT and prognosis
Time frame: 3 year
Compare SUVmax, tumor/liver ratio as a prognostic marker
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by Peking University at 1 site in China.
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 10 inclusion and 4 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 20 Sep 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 China. 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?
Contact Lin Shen, Professor (01088196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between the positive rate and SUVs of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT and treatment response (time frame: 3 years). It is what the study was designed to measure, not a finding.
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 20 Sep 2017.