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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04069299




Registration number
NCT04069299
Ethics application status
Date submitted
22/08/2019
Date registered
28/08/2019
Date last updated
1/10/2024

Titles & IDs
Public title
Use of 68Ga-dotatate PET Scan in Neuroendocrine Carcinoma of the GI Tract
Scientific title
Somatostatin Receptor Expression in Poorly-Differentiated Neuroendocrine Carcinomas of the GI Tract: Analysis Using 68Ga-dotatate PET Scan
Secondary ID [1] 0 0
MCC-19943
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - 68Ga-DOTATATE
Diagnosis / Prognosis - Positron Emission Tomography (PET) Scan

Participants receiving PET scan - Participants with metastatic poorly-differentiated neuroendocrine carcinomas of the GI tract


Treatment: Drugs: 68Ga-DOTATATE
The NETspot kit is 2 vials, Vial 1 contains 40 mcg dotatate, 5 mcg 1,10phenanthroline; 6mcg gentisic acid and 20 mg mannitol. Vial 2 contains 60 mg formic acid, 56.5 mg sodium hydroxide and water for injection

Diagnosis / Prognosis: Positron Emission Tomography (PET) Scan
PET scan is an imaging test using radioactive tracers.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Uniformly Positive 68Ga-dotatate PET
Timepoint [1] 0 0
Up to 10 months
Secondary outcome [1] 0 0
Percentage of Participants with No Uptake to Very High Uptake on PET
Timepoint [1] 0 0
Up to 10 months

Eligibility
Key inclusion criteria
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female = 18 years old
* Histologically confirmed diagnosis of poorly-differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract or unknown primary
* Evidence of measurable disease per RECIST 1.1 on another imagine modality (CT, MRI or FDGPET) with at least 3 tumors >1cm in largest diameter. CT, MRI or Fluorodeoxyglucose (FDG)-PET must have been performed within 2 months of the study scan. (Of note, participants may sign consent for the study prior to scheduling of said CT, MRI or FDG-PET, but will be considered screen failures if the CT/MRI/FDG-PET does not reveal at least 3 tumors >1cm).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with well-differentiated neuroendocrine tumors
* Participants who have undergone 68Ga-dotatate PET scan in the past
* Pregnant women and/or breastfeeding women. Women of child bearing potential must have a negative pregnancy test prior to scan.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Other
Name
H. Lee Moffitt Cancer Center and Research Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Advanced Accelerator Applications
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to understand the extent and degree of somatostatin receptor expression in poorly differentiated neuroendocrine carcinomas . This may help to make a determination if a radiolabeled somatostatin analog therapy, also referred to as peptide receptor radiotherapy (PRRT), can be a potential alternative in the future. At this time, radiolabeled somatostatin analogs have not been tested in patients with poorly differentiated neuroendocrine carcinomas, and their efficacy in this disease is not well known Understanding the extent and degree of somatostatin receptor expression is important in order to evaluate the potential of radiolabeled somatostatin analog therapy for treatment of poorly differentiated neuroendocrine carcinomas.
Trial website
https://clinicaltrials.gov/study/NCT04069299
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Jonathan Strosberg, MD
Address 0 0
H Lee Moffitt Cancer & Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04069299