Explore the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms

September 16, 2017 updated by: Shen Lin, Peking University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neuroendocrine neoplasmes

Description

Inclusion Criteria:

  1. sign written informed consent form
  2. age ≥ 18 years
  3. pathologically confirmed neuroendocrine, Ki67>=10%;
  4. ECOG 0-1;
  5. No prior antitumor treatment with chemotherapy targeting regimens for neuroendocrine carcimomas, no more than 2 systematic treatment for neuroendocrine tumors;
  6. Unresectable disease;
  7. 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);
  8. Predicted survival >=3 months;
  9. Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women;
  10. Sexually active males or females willing to practice contraception during the study until 30 days after end of study.

Exclusion Criteria:

  1. In the process of antitumor therapy with effective response;
  2. Refuse to accept PET/CT;
  3. Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;
  4. Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons；

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A: advanced and metastatic neuroendocrine tumors
Advanced and metastatic neuroendocrine tumors receive syestematic treatment
Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NET
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
A: advanced and metastatic neuroendocrine carcinomas
Advanced and metastatic neuroendocrine carcinomas receive syestematic treatment
Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NEC
At the beginning of the treatment with chemotherapy 4-6 cycles or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The correlation between positive rate and SUV of PET/CT and prognosis
Time Frame: 3 year
3 year
Compare SUVmax, tumor/liver ratio as a prognostic marker
Time Frame: 3 year
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

September 16, 2017

First Submitted That Met QC Criteria

September 16, 2017

First Posted (Actual)

September 20, 2017

Study Record Updates

Last Update Posted (Actual)

September 20, 2017

Last Update Submitted That Met QC Criteria

September 16, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68Ga&FDG PET/CT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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