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NCT Number: NCT06715839

Target-specific immunoPET Imaging of Digestive System Carcinoma

The aim of this study is to establish and optimize the target-specific PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated.

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Key information

Conditions

Malignancy Appendiceal Neoplasms Appendix Cancer Bile Duct Carcinoma Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Cecal Diseases Cecal Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive Cancer Digestive System Cancer Digestive System Carcinoma Digestive System Diseases Digestive System Neoplasm Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Esophagus Cancer Gallbladder Carcinoma Gallbladder Diseases Gallbladder Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Rectal Neoplasms Rectum Cancer Simpson-Golabi-Behmel syndrome Small Intestine Cancer Stomach Cancer Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Enrolled patients will undergo whole-body PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents in tumor and normal organs/tissues will be scored visually and quantitatively.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-75 years old and of either sex；
  • Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging;
  • Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.

Exclusion criteria

  • Pregnancy；
  • Severe hepatic and renal insufficiency;
  • History of serious surgery in the last month;
  • Allergic to antibody or single-domain antibody radiopharmaceuticals.

Treatment and study plan

[68Ga]Ga-DOTA-H2D3

Drug

Enrolled patients (especially those with gastric cancer) will receive 0.05-0.1 mCi/kg of a HER2-targeted probe ([68Ga]Ga-DOTA-H2D3). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-DOTA-H2D3 injection.

Other names: [68Ga]Ga-H2D3

[18F]F-RESCA-RB14

Drug

Enrolled patients (especially those with gastric cancer) will receive 0.05-0.1 mCi/kg of a HER2-targeted probe ([18F]F-RESCA-RB14). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-RB14 injection.

Other names: [18F]F-RB14

[68Ga]Ga-NOTA-T4

Drug

Enrolled patients (especially those with gastric cancer/pancreatic cancer) will receive 0.05-0.1 mCi/kg of a Trop2-targeted probe ([68Ga]Ga-NOTA-T4). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-T4 injection.

Other names: [68Ga]Ga-T4

[18F]F-RESCA-T4

Drug

Enrolled patients (especially those with gastric cancer/pancreatic cancer) will receive 0.05-0.1 mCi/kg of a Trop2-targeted probe ([18F]F-RESCA-T4). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-T4 injection.

Other names: [18F]F-T4

[68Ga]Ga-NOTA-G5

Drug

Enrolled patients (especially those with hepatocellular carcinoma) will receive 0.05-0.1 mCi/kg of a GPC3-targeted probe ([68Ga]Ga-NOTA-G5). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-G5 injection.

Other names: [68Ga]Ga-G5

[18F]F-RESCA-G5

Drug

Enrolled patients (especially those with hepatocellular carcinoma) will receive 0.05-0.1 mCi/kg of a GPC3-targeted probe ([18F]F-RESCA-G5). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-G5 injection.

Other names: [18F]F-G5

[68Ga]Ga-NOTA-WWH347

Drug

Enrolled patients (especially those with colorectal cancer) will receive 0.05-0.1 mCi/kg of a GPA33-targeted probe ([68Ga]Ga-NOTA-WWH347). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-WWH347 injection.

Other names: [68Ga]Ga-WWH347

[18F]F-RESCA-WWH347

Drug

Enrolled patients (especially those with colorectal cancer) will receive 0.05-0.1 mCi/kg of a GPA33-targeted probe ([18F]F-RESCA-WWH347). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-WWH347 injection.

Other names: [18F]F-WWH347

[68Ga]Ga-NOTA-RND20

Drug

Enrolled patients will receive 0.05-0.1 mCi/kg of a Nectin-4-targeted probe ([68Ga]Ga-NOTA-RND20). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-RND20 injection.

Other names: [68Ga]Ga-RND20

[18F]F-RESCA-RND20

Drug

Enrolled patients will receive 0.05-0.1 mCi/kg of a Nectin-4-targeted probe ([18F]F-RESCA-RND20). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-RND20 injection.

Other names: [18F]F-RND20

Primary outcomes

  1. Biodistribution

    Time frame: 1 day from injection of the tracers

    Measurement of the overall biodistribution of above tracers in normal tissues and organs.

  2. Standardized uptake value (SUV)

    Time frame: 1 day from injection of the tracers

    Standardized uptake value (SUV) of above tracers in the included subjects' primary and/or metastatic lesions.

  3. Radiation dosimetry

    Time frame: 1 day from injection of the tracers

    Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs, tumor(s), and whole body (Sv/MBq). Dynamic imaging within one hour will be acquired for the purpose.

  4. Diagnostic value in patients with digestive system malignancy

    Time frame: 30 days

    Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics and, more importantly, the clinical value of these target-specific tracers in patients with malignancies of the digestive system.

  5. The correlation between the expression of specific target and tracer uptake value

    Time frame: 60 days

    The Standardized uptake value (SUV) will be calculated, and the correlation between pathological results and tumor uptake of these tracers will be analyzed.

Secondary outcomes

  1. Predictive value of these tracers in the course of combined immunotherapies and targeted therapies

    Time frame: 3-6 months

    Baseline and follow-up immunoPET imaging in combined immunotherapies and targeted therapies (four to eight cycles) will be investigated in this setting to determine the value of the immunoPET imaging in predicting or evaluating treatment responses.

  2. Target-specific PET/CT in changing clinical decision-making for patients with digestive system malignancy

    Time frame: 3-6 months

    After analyzing the imaging parameters and diagnostic/predictive value of these target-specific tracers, we will also investigate how clinical use of these tracers changes clinical decision-making for patients with malignant tumors of the digestive system. Joint efforts from nuclear medicine physicians, surgeons, oncologists, and pathologists will draw solid conclusions from the imaging and clinical information.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

17717453484

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

CONTACT

[email protected]

15000083153

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Development and Clinical Translation of immunoPET Imaging Probes for Digestive System Carcinoma

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 4, 2024
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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