NCT03288597

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

September 16, 2017

Last Update Submit

September 16, 2017

Conditions

Neuroendocrine Tumors

Keywords

positive rateSUVmaxrelationship

Outcome Measures

Primary Outcomes (1)

  • The correlation between the positive rate and SUVs of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT and treatment response

    3 years

Secondary Outcomes (2)

  • The correlation between positive rate and SUV of PET/CT and prognosis

    3 year

  • Compare SUVmax, tumor/liver ratio as a prognostic marker

    3 year

Study Arms (2)

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

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

Interventions

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

A: advanced and metastatic neuroendocrine tumors
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

A: advanced and metastatic neuroendocrine carcinomas

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Neuroendocrine neoplasmes

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Central Study Contacts

Lin Shen, Professor

CONTACT

01088196561linshenpku@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital

Study Record Dates

First Submitted

September 16, 2017

First Posted

September 20, 2017

Study Start

September 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2020

Last Updated

September 20, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)