NCT06056362

Brief Summary

This prospective, single-center, double-blinded study investigates the biodistribution, dosimetry, safety, and diagnostic ability of Al18F-NOTA-LM3 in patients with well-differentiated neuroendocrine tumors. And compares the diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PET/CT and 68Ga-NODAGA-LM3 PET/CT. Clinical management will also be compared using different imaging modalities.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2023

Typical duration for phase_1

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

First Submitted

Initial submission to the registry

March 19, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

March 23, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2025

Completed
Last Updated

April 2, 2025

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

March 19, 2023

Last Update Submit

March 27, 2025

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (7)

  • Safety of Al18F-NOTA-LM3

    Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan.

    From radiotracer injection to 24 hours post-injection.

  • Detection rate of Al18F-NOTA-LM3 on per-patient basis

    Percentage of patients with lesions detected on Al18F-NOTA-LM3 PET/CT.

    From study completion to 6 months after completion.

  • SUVmax of lesions detected on Al18F-NOTA-LM3 PET/CT

    The tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest.

    From study completion to 6 months after completion.

  • Detection rate of 68Ga-DOTATATE on per-patient basis

    Percentage of patients with lesions detected on 68Ga-DOTATATE PET/CT.

    From study completion to 6 months after completion.

  • SUVmax of lesions detected on 68Ga-DOTATATE PET/CT

    The tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest.

    From study completion to 6 months after completion.

  • Detection rate of 68Ga-NODAGA-LM3 on per-patient basis

    Percentage of patients with lesions detected on 68Ga-NODAGA-LM3 PET/CT.

    From study completion to 6 months after completion.

  • SUVmax of lesions detected on 68Ga-NODAGA-LM3 PET/CT

    The tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest.

    From study completion to 6 months after completion.

Secondary Outcomes (2)

  • SUVmax of normal organs

    From study completion to 6 months after completion.

  • Absorbed dose of target organs

    From study completion to 6 months after completion.

Study Arms (2)

Arm A: Al18F-NOTA-LM3 and 68Ga-DOTATATE group

EXPERIMENTAL

Patients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-DOTATATE PET/CT.

Diagnostic Test: Al18F-NOTA-LM3Diagnostic Test: 68Ga-DOTATATE

Arm B: Al18F-NOTA-LM3 and 68Ga-NODAGA-LM3 group

EXPERIMENTAL

Patients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-NODAGA-LM3 PET/CT.

Diagnostic Test: Al18F-NOTA-LM3Diagnostic Test: 68Ga-NODAGA-LM3

Interventions

Al18F-NOTA-LM3DIAGNOSTIC_TEST

40 patients will be enrolled in this arm. The first enrolled 8 patients will undergo serial whole-body PET/CT scans at multiple time points (5, 15, 30, 45, 60, and 120 min) after injection of Al18F-NOTA-LM3. The following patients will undergo a whole-body PET/CT scan 60-120 minutes after injection.

Arm A: Al18F-NOTA-LM3 and 68Ga-DOTATATE group
68Ga-DOTATATEDIAGNOSTIC_TEST

All patients in arm A will undergo a whole-body PET/CT scan 40-60 minutes after injection of 68Ga-DOTATATE. 68Ga-DOTATATE PET/CT and Al18F-NOTA-LM3 PET/CT should be performed within a week and the interval between the two scans at least 24h.

Arm A: Al18F-NOTA-LM3 and 68Ga-DOTATATE group
68Ga-NODAGA-LM3DIAGNOSTIC_TEST

All patients in arm B will undergo a whole-body PET/CT scan 40-60 minutes after injection of 68Ga-NODAGA-LM3. 68Ga-NODAGA-LM3 PET/CT and Al18F-NOTA-LM3 PET/CT should be performed within a week and the interval between the two scans at least 24h.

Arm B: Al18F-NOTA-LM3 and 68Ga-NODAGA-LM3 group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 to 80 years.
  • Histologically proven, well-differentiated, NETs (G1 or G2).
  • No long-acting somatostatin analog treatment within 4 weeks.
  • No PRRT treatment within 8 weeks.

You may not qualify if:

  • Combined with other types of tumors.
  • Severe liver or renal dysfunction (ALT/AST≥5 ULN, GFR\<30ml/min).
  • Active infection.
  • Pregnant or breast-feeding women.
  • Inability to perform PET/CT scans.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Related Publications (2)

  • Liu M, Zhang Y, Yan X, Zhang H, Ren C, Huang Z, Cheng Y, Xu Q, Li Y, Jia R, Zhu W, Huo L. Assessment of the diagnostic efficacy and clinical significance of [18F]AlF-NOTA-LM3 PET/CT in patients with well-differentiated neuroendocrine tumors. Eur J Nucl Med Mol Imaging. 2025 Aug 5. doi: 10.1007/s00259-025-07484-9. Online ahead of print.

    PMID: 40762797DERIVED

  • Liu M, Ren C, Zhang H, Zhang Y, Huang Z, Jia R, Cheng Y, Bai C, Xu Q, Zhu W, Huo L. Evaluation of the safety, biodistribution, dosimetry of [18F]AlF-NOTA-LM3 and head-to-head comparison with [68Ga]Ga-DOTATATE in patients with well-differentiated neuroendocrine tumors: an interim analysis of a prospective trial. Eur J Nucl Med Mol Imaging. 2024 Oct;51(12):3719-3730. doi: 10.1007/s00259-024-06790-y. Epub 2024 Jun 15.

    PMID: 38878175DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

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

Study Officials

  • Meixi Liu, MD

    Peking Uion Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meixi Liu, MD

CONTACT

+86-15010405355meixiliu_pumc@126.com

Li Huo, MD

CONTACT

+86-13910801986huoli@pumch.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The images of patients will be reviewed by 2 experienced nuclear medicine physicians and they will be masked to all patients' clinical information.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2023

First Posted

September 28, 2023

Study Start

March 23, 2023

Primary Completion

March 27, 2025

Study Completion

March 27, 2025

Last Updated

April 2, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)