CClinicalTrials.gg
CompletedNCT05990998Updated Feb 26, 2024

A Head-to-head Comparison of [68Ga]Ga-FAPI and [68Ga]Ga-TATE PET/CT in Patients With Nasopharyngeal Carcinoma: a Single-center, Prospective Study

A Phase 1/2 interventional study of 68Ga-DOTATATE and 68Ga-FAPI in Tumor Positron-Emission Tomography, sponsored by First Affiliated Hospital of Fujian Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-02-26.

Sponsored by First Affiliated Hospital of Fujian Medical University · Phase 1/2, Interventional, and Diagnostic

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Nov 2022, registered Aug 2023).
Phase
Phase 1/2
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Both fibroblast activation protein (FAP)-targeted imaging and somatostatin receptors (SSTR)-targeted imaging were the promising imaging modalities for the diagnosis of primary and metastatic nasopharyngeal carcinoma (NPC). This prospective study is going to investigate to compare the diagnostic efficacy of 68Ga-FAPI and 68Ga-DOTATATE in detecting primary and metastatic NPC lesions, thereby obtaining a more accurate examination method of NPC.

Read the detailed description

Patients with newly diagnosed or previously treated NPC will be recruited in this study.

Each patient received an intravenous injection of 68Ga-DOTATATE (2-4mCi) on the first day and 68Ga-FAPI (2-4mCi) on the second day. Whole-body PET/CT scans were performed at 40-60 min after injection on the same scanner. Physiologic normal-organ uptake, lesion numbers, and lesion uptake were compared.

02

Conditions studied

  • Tumor Positron-Emission Tomography
03

In context

Lead sponsor

First Affiliated Hospital of Fujian Medical University is the lead sponsor of 92 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients of either gender, aged ≥ 18 years.

    • Patients with newly diagnosed or previously treated NPC
    • A diagnostic magnetic resonance imaging (MRI) of the tumor region within the previous 1 weeks prior to dosing day is available.
    • signed written consent.

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • breastfeeding
  • the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Patients will undergo a 68Ga-FAPI PET/CT and 68Ga-DOTATATE PET/CT

    NPC patients receive a single intravenous injection of 68Ga-FAPI PET/CT and 68Ga-DOTATATE PET/CT (2-4mCi) PET/CT,and undergo PET/CT scan at 40-60 min post-injection.

    Drug: 68Ga-DOTATATE and 68Ga-FAPI

Interventions

  • Drug68Ga-DOTATATE and 68Ga-FAPI

    Each patient receive a single intravenous injection of 68Ga-FAPI or 68Ga-DOTATATE (2-4mCi) , and undergo PET/CT scan at 40-60 min post injection.

06

What researchers measure

Primary outcomes

  1. SUVmax

    Determination of SUV for detected lesions and discernible organs of 68Ga-FAPI and 68Ga-DOTATATE scan.

    Time frame: through study completion, an average of 2 years

  2. Lesion numbers

    Determination of lesion numbers of 68Ga-FAPI and 68Ga-DOTATATE scan.

    Time frame: through study completion, an average of 2 years

07

Study locations

1 site
  • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
    Fuzhou, Fujian 350005, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05990998
Lead sponsor
First Affiliated Hospital of Fujian Medical University
Responsible party
Weibing Miao, PhD (Director of Nuclear Medicine Department, First Affiliated Hospital of Fujian Medical University) — Principal investigator
First posted
Aug 14, 2023
Start date
Nov 20, 2022
Primary completion
Aug 31, 2023
Completion
Sep 1, 2023
Last update
Feb 26, 2024

Study contacts

Weibing Miao, M.D.
principal investigator · First Affiliated Hospital of Fujian Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion