NCT05709171

Brief Summary

Prospective clinical trial investigating combined, dual 18F-FDG PET/CT and 64Cu-DOTATATE PET/CT imaging of patients with gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN)

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
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2023

Typical duration for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

January 24, 2023

Last Update Submit

November 20, 2023

Conditions

GEP-NETNeuroendocrine TumorsNeuroendocrine CarcinomaNeuroendocrine Carcinoma Metastatic

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS)

    Time to disease progression from PET/CT scans. Disease progression is defined as a composite measure (whichever occurs first) of RECIST-1.1 defined radiological progression, commencement of another systemic therapy and/or surgery/embolization/ablation related to worsening to the patient's disease status after the index scan, progression evaluated by a multidisciplinary tumor board, and death related to the patient's NEN disease. In case of uncertainty if progression has occurred, the patient's disease status will be evaluated by a multidisciplinary tumor board.

    12 months after last-patients-last-visit

Secondary Outcomes (3)

  • Overall survival (OS)

    12 months after last-patients-last-visit

  • Correlation between tumor standardized uptake values (SUV) on 18F-FDG PET and 64Cu-DOTATATE PET

    12 months after last-patients-last-visit

  • Proportion of patients eligible for peptide receptor radionuclide therapy (PRRT)

    12 months after last-patients-last-visit

Study Arms (1)

Experimental

EXPERIMENTAL

Each patient will undergo one standard of care 18FDG PET/CT and one 64Cu-DOTATATE PET/CT within 4 weeks.

Drug: 18F-FDGDrug: 64Cu-Dotatate

Interventions

18F-FDGDRUG

PET/CT scan approximately 60 min after injection of 18F-FDG

Also known as: 18F-fluorodeoxyglucose, fluorodeoxyglucose-F-18, [18F]F-FDG
Experimental
64Cu-DotatateDRUG

PET/CT scan approximately 60 min after injection of 64Cu-Dotatate

Also known as: Copper (64Cu) oxodotreotide
Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histopathologically verified gastro-entero-pancreatic neuroendocrine neoplasm (GEP-NEN) or patients with unknown primary tumor with metastases with verified NEN positive histopathological examination suggesting GEP origin
  • World Health Organization (WHO) Performance status 0-2
  • Must be able to read and understand the patient information in Danish and to give informed consent

You may not qualify if:

  • Pregnancy
  • Breast-feeding
  • Weights more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)
  • Uncontrolled diabetes
  • Uncontrolled infection
  • Exacerbation in autoimmune diseases
  • Other active cancer disease
  • Conditions or diseases (e.g. uncontrolled Parkinson's disease) making the patient unable to lie still in the scanner
  • Severe claustrophobia
  • Localized neuroendocrine neoplasms of the appendix, the rectum measuring \< 1 cm, and ECL-omas of the stomach
  • History of allergic reaction attributable to compounds of similar chemical or biologic com-position to 18FDG or 64Cu-DOTATATE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumorNeuroendocrine TumorsCarcinoma, Neuroendocrine

Interventions

Fluorodeoxyglucose F1864Cu-DOTATATECoppercopper dotatate CU-64

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueAdenocarcinomaCarcinomaNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Andreas Kjaer, MD

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 2, 2023

Study Start

January 17, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Individual participant data are not publicly available due to protection of personal data according to data protection regulations and medical confidentiality.

Locations

DK(1)