CClinicalTrials.gg
Status unknownNCT05691881Updated Jan 20, 2023

68Ga-labeled NY105 PET Imaging in Patients

An Early Phase 1 interventional study of 68Ga-NY105 in Cancer, sponsored by Affiliated Hospital of Jiangnan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-20.

Sponsored by Affiliated Hospital of Jiangnan University · Early Phase 1, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2022, registered Jan 2023).
Phase
Early Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY105 PET Imaging in patients

02

Conditions studied

  • Cancer
03

In context

Lead sponsor

Affiliated Hospital of Jiangnan University is the lead sponsor of 28 studies on the registry; 11 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients voluntarily signed informed consent;
  2. Age 18-75, male or female;
  3. Patients diagnosed with cancer confirmed by histopathology or cytology;
  4. At least one measurable solid lesion has been examined according RECIST1.1 standard;
  5. ECOG score 0\~3.

Exclusion criteria

Exclusion Criteria:

  1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
  2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
  3. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
  4. Patients with autoimmune diseases, including rheumatoid arthritis;
  5. Inadequate control of arrhythmias, including atrial fibrillation;
  6. Uncontrolled hypertension;
  7. Patients with allergies or allergies to any component of the imaging agent or antibody;
  8. Patients who cannot undergo PET/CT imaging scan;
  9. Syphilis, HBV, HCV, or HIV positive subjects;
  10. Male and female subjects of reproductive age cannot take effective contraceptive measures;
  11. Pregnant or lactating women;
  12. Patients with a history of mental illness or related conditions;
  13. Other subjects considered unsuitable by researchers.
05

Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    68Ga-NY105

    Drug: 68Ga-NY105

Interventions

  • Drug68Ga-NY105

    Patients will receive a tracer (20-40mcg, IV) dose of 68Ga (2-5mCi) labelled NY105

06

What researchers measure

Primary outcomes

  1. Evaluation of tissue distribution of 68Ga-NY105

    Biodistribution of 68Ga-NY105 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported.

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Affiliated Hospital of Jiangnan University
    Wuxi, 214000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05691881
Lead sponsor
Affiliated Hospital of Jiangnan University
Responsible party
Chunjing Yu (Director, Affiliated Hospital of Jiangnan University) — Principal investigator
First posted
Jan 20, 2023
Start date
Sep 28, 2022
Primary completion
Mar 2023 (estimated)
Completion
Sep 2023 (estimated)
Last update
Jan 20, 2023

Study contacts

Chunjing Yu
Contact
ycj_wxd1978@163.com
15312238622
Chunjing Yu
principal investigator · Affiliated Hospital of Jiangnan University

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jan 2023. 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