AzTrials
AzTrials

Neoplasms PancreaticNCT06602037

ImmunoPET Imaging of Pancreatic Cancer

A study testing [89Zr]Zr-DFO-SHR1920, [18F]F-RESCA-3A12 and [68Ga]Ga-NOTA-3A12 in people with Neoplasms Pancreatic, run by RenJi Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Pancreatic cancer remains one of the most aggressive cancer types. Target-specific targeted therapy is an attractive therapeutic alternative for the treatment of patients with a wide range of cancers, including pancreatic cancer. Companion diagnostic technique is critical for the success of targeted therapies. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Neoplasms Pancreatic
What is being tested?
[89Zr]Zr-DFO-SHR1920, [18F]F-RESCA-3A12 and [68Ga]Ga-NOTA-3A12
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
20 Nov 2024to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of pancreatic cancer or suspected pancreatic cancer by diagnostic imaging.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Who cannot join

  • Known or suspected hypersensitivity to SHR1920, DFO/RESCA/NOTA, 89Zr/18F or 68Ga or any of the excipients.
  • Pregnancy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Weijun Wei, Ph.D. & M.D. contact

15000083153

wwei@shsmu.edu.cn

Shuxian An, Ph.D. & M.D. contact

17717453484

anshuxian@shsmu.edu.cn

China1 site, 1 recruiting

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, 200127

    Weijun Wei, PhD, 15000083153, wwei@shsmu.edu.cn

    Shuxian An, PhD, 17717453484, anshuxian@shsmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Development and Clinical Translation of immunoPET Imaging Probes for Pancreatic Cancer

Pancreatic cancer remains one of the most aggressive cancer types. Target-specific targeted therapy is an attractive therapeutic alternative for the treatment of patients with a wide range of cancers, including pancreatic cancer. Companion diagnostic technique is critical for the success of targeted therapies. SHR-A1921 is a TROP2-directed antibody-drug-conjugate (ADC) approved for several clinical trials for advanced solid tumors. SHR1920 is the humanized anti-Trop2 monoclonal antibody (hIgG1) of SHR-A1921. Radio-labeling SHR1920 with radionuclide Zirconium-89 (89Zr) enables non-invasive imaging and quantification of SHR-A1921 distribution in cancer patients. Performing a [89Zr]Zr-DFO-SHR1920 PET scan before treatment with SHR-A1921 can evaluate tracer uptake in the primary and metastatic tumor lesions and normal organ distribution. CLND18.2 is another potential therapeutic target for pancreatic cancer. Target-specific immunoPET imaging may help identify patients more likely to benefit from targeted therapy.

Read the detailed description

Enrolled patients with pancreatic cancer will undergo whole-body [89Zr]Zr-DFO-SHR1920 immunoPET/CT scans at 0,1, 3, 5, or 7 days after tracer injection (1-3 mCi). Uptake of [89Zr]Zr-DFO-SHR1920 in tumor and normal organs/tissues will be scored visually and quantitatively. For immunoPET imaging with 18F or 68Ga-labeled 3A12 (a nanobody targeting CLDN18.2), immunoPET/CT scan will be performed 1h after tracer injection (0.05-0.1 mCi/kg).

Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.

Being tested
[89Zr]Zr-DFO-SHR1920, [18F]F-RESCA-3A12, [68Ga]Ga-NOTA-3A12
Keywords
Pancreatic cancer, ImmunoPET, Companion Diagnostics, Trop2, CLDN18.2（Claudin 18.2）, Gastric cancer, Solid tumors
Medical subject headings
Pancreatic Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [89Zr]Zr-DFO-SHR1920Diagnostic test

    Also called [89Zr]Zr-SHR1920

    Enrolled pancreatic cancer patients will receive a single dose (1-3mCi) of [89Zr]Zr-DFO-SHR1920 (total 1-2mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).

  • [18F]F-RESCA-3A12Diagnostic test

    Also called [18F]F-3A12

    Enrolled pancreatic cancer patients will receive 0.05-0.1mCi/kg of [18F]F-RESCA-3A12. ImmunoPET/CT imaging will be acquired 1h after [18F]F-RESCA-3A12 injection.

  • [68Ga]Ga-NOTA-3A12Diagnostic test

    Also called [68Ga]Ga-3A12

    Enrolled pancreatic cancer patients will receive 0.05-0.1mCi/kg of [68Ga]Ga-NOTA-3A12. ImmunoPET/CT imaging will be acquired 1h after [68Ga]Ga-NOTA-3A12 injection.

Study groups in NCT06602037
Study groupRoleWhat they receive
ImmunoPET imaging in patients with pancreatic cancersExperimentalEnrolled pancreatic cancer patients (locally advanced or metastatic cancer) will undergo a Trop2/CLDN18.2-targeted immunoPET/CT scanning.
Receives: Diagnostic Test: [89Zr]Zr-DFO-SHR1920; Diagnostic Test: [18F]F-RESCA-3A12; Diagnostic Test: [68Ga]Ga-NOTA-3A12

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SUV

    Standardized uptake value (SUV) of [89Zr]Zr-DFO-SHR1920、[18F]F-RESCA-3A12 or [68Ga]Ga-NOTA-3A12 for each primary tumor of subject or suspected metastasis.

    Measured: 7 days

  2. Biodistribution and radiation dosimetry of [89Zr]Zr-DFO-SHR1920

    Measurement of absorbed radiation doses to organs (Gy/MBq), tumour(s) and whole body (Sv/MBq).

    Measured: 7 days

Secondary outcomes (3)

  1. Sensitivity, Specificity, Positive predictive value (PPV), Negative predictive value (NPV) and accuracy

    The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of [89Zr]Zr-DFO-SHR1920、[18F]F-RESCA-3A12 or [68Ga]Ga-NOTA-3A12 PET/CT will be calculated.

    Measured: 30 days

  2. Trop2 expression and SUV

    The Standardized uptake value (SUV) of [89Zr]Zr-DFO-SHR1920 will be calculated and the correlation between pathological results and tumor uptake of [89Zr]Zr-DFO-SHR1920 will be analyzed

    Measured: 30 days

  3. CLDN18.2 expression and SUV

    The Standardized uptake value (SUV) of [18F]F-RESCA-3A12 or [68Ga]Ga-NOTA-3A12 will calculated and the correlation between pathological results and tumor uptake of [18F]F-RESCA-3A12 or [68Ga]Ga-NOTA-3A12 will be analyzed.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start20 Nov 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06602037
Sponsor's protocol ID
KY2024-067-C
Status last verified
Dec 2025
First submitted
9 Sep 2024
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing [89Zr]Zr-DFO-SHR1920, [18F]F-RESCA-3A12 and [68Ga]Ga-NOTA-3A12 in people with Neoplasms Pancreatic, run by RenJi Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Weijun Wei, Ph.D. & M.D. (15000083153, wwei@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SUV (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06602037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in