NCT05673031

Brief Summary

To determine if 68Ga-HA-DOTATATE PET/CT imaging is effective at diagnosing somatostatin positive tumors compared to conventional imaging \[including CT, MRI, 111 In-pentetreotide Scans, 18F-FDG PET/CT, as available\]

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress83%
Feb 2023Jan 2027

First Submitted

Initial submission to the registry

January 3, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

3.9 years

First QC Date

January 3, 2023

Last Update Submit

January 4, 2023

Conditions

Neuroendocrine Tumors (NET)

Outcome Measures

Primary Outcomes (1)

  • 68Ga-HA-DOTATATE PET/CT imaging

    To compare 68Ga-HA-DOTATATE PET/CT imaging at identifying somatostatin positive tumors to conventional imaging \[including CT, MRI, 111 In-pentetreotide Scans, 18F-FDG PET/CT, as available\]. 68Ga-HA-DOTATATE PET/CT scans will be evaluated for abnormal accumulation of 68Ga-HA-DOTATATE. Any abnormal uptake will be determined for up to 5 lesions and compared to results of standard of care imaging performed \[including CT, MRI, 111 In-pentetreotide (OctreoscanTM) Scan with SPECT/CT, 18F-FDG PET/CT, as available\] for presence/absence of each lesion. Comparison to any follow up 68Ga-HA-DOTATATE PET/CT Scans will also be performed (up to 5 follow up68Ga-HA-DOTATATE PET/CT Scans will be allowed).

    5 years

Study Arms (1)

68Ga-HA-DOTATATE

68Ga-HA-DOTATATE Intravenous injection of 100-250 MBq 68Ga-HA-DOTATATE

Diagnostic Test: 68Ga-HA-DOTATATE PET/CT imaging

Interventions

68Ga-HA-DOTATATE PET/CT imagingDIAGNOSTIC_TEST

Each patient will receive an IV injection 68Ga-HA-DOTATATE. Imaging will be conducted beginning 45-90 minutes after an injection of between 100-250 MBq 68Ga-HA-DOTATATE in patients. * After the 68Ga-HA-DOTATATE acquisition is complete, a CT scan will be performed for attenuation correction and localization in the same in line gantry without patient movement between the two scans. * The results of the 68Ga-HA-DOTATATE PET/CT will be compared to any prior imaging and pathologic results.

68Ga-HA-DOTATATE

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinically suspected (patients presenting with symptom(s) suggestive of carcinoid syndrome or biochemically suggestive of Neuroendocrine Tumor) or Biopsy proven Neuroendocrine Tumor. Patients greater than 18 years of age who are able to follow instructions and provide written consent to participate in study.

You may qualify if:

  • Male or female. If female of child-bearing potential and outside of the window of 10 days since the last menstrual period, a negative pregnancy test will be required.
  • Age greater than or equal to 18 years.
  • Able and willing to follow instructions and comply with the protocol.
  • Provide written informed consent prior to participation in the study.
  • Clinically suspected (patients presenting with symptom(s) suggestive of carcinoid syndrome or biochemically suggestive of Neuroendocrine Tumor) or Biopsy proven Neuroendocrine Tumor

You may not qualify if:

  • Nursing or pregnant females.
  • Age less than 18 years.
  • Surgery in the area of interest within the preceding 2 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Center 1403 29 St NW

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 5, 2023

Study Start

February 1, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)