NCT07059832

Brief Summary

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-NODAGA-SNA006 in subjects with solid tumor or lymphoma.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
22mo left

Started Apr 2024

Typical duration for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
active not 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 Progress55%
Apr 2024Apr 2028

Study Start

First participant enrolled

April 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

3.8 years

First QC Date

June 24, 2025

Last Update Submit

July 1, 2025

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

  • Incidence of 68Ga-NODAGA-SNA006-emergent Adverse Events

    Through PET/CT, Visual analysis was positive, or the SUVmax was more than the mediastinum

    3 YEAR

  • Biodistribution of 68Ga-NODAGA-SNA006

    Through PET/CT analysis, SUVmax and SUVmean of the organs

    3 YEAR

Secondary Outcomes (1)

  • Correlation analysis of 68Ga-NODAGA-SNA006 uptake and tumor immune phenotype

    3 YEAR

Study Arms (1)

Feasibility and safety of 68Ga-NODAGA-SNA006

EXPERIMENTAL

68Ga-NODAGA-SNA006 0.05 mCi/Kg, interval time between FDG was within five days

Drug: 68Ga-NODAGA-SNA006

Interventions

68Ga-NODAGA-SNA006DRUG

68Ga-NODAGA-SNA006 PET/CT: after intravenous injection of 0.05 mCi/kg body weight of quality-controlled 68Ga-NODAGA-SNA006, an integrated PET/CT scanner (Biograph mCT; Siemens, Germany) will be applied.

Feasibility and safety of 68Ga-NODAGA-SNA006

Eligibility Criteria

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

You may qualify if:

  • Participants who were diagnosed with malignant tumors;
  • Patients are between 18 and 80 years of age are between 18 and 80 years of age.

You may not qualify if:

  • Participants who were unable or unwilling to provide written informed consent.
  • Participants who were unable to successfully complete the examination and are forced to abort the test in the middle of the test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • li

    First Hospital of China Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 11, 2025

Study Start

April 1, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

July 11, 2025

Record last verified: 2025-07

Locations

CN(1)