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

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ClinicalTrials.gov Identifier: NCT03288597
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University

Brief 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. The study was designed to confirm thet clinical values of dual imagings for neuroendocrine tumors.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NET Radiation: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NEC

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 146 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: A Prospective Exploration in the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The correlation between positive rate and SUV of PET/CT and prognosis [ Time Frame: 3 year ]
  2. Compare SUVmax, tumor/liver ratio as a prognostic marker [ Time Frame: 3 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neuroendocrine neoplasmes
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288597


Contacts
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Contact: Lin Shen, Professor 01088196561 linshenpku@163.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Shen Lin, Professor    010-88196561    Linshenpku@163.com   
Principal Investigator: Shen Lin, professor         
Sponsors and Collaborators
Peking University

Additional Information:

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Responsible Party: Shen Lin, MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital, Peking University
ClinicalTrials.gov Identifier: NCT03288597     History of Changes
Other Study ID Numbers: 68Ga&FDG PET/CT
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shen Lin, Peking University:
positive rate
SUVmax
relationship
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals