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NCT Number: NCT06597539

The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy

This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for advanced hepatobiliary malignancies.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Biao Li

CONTACT

Feng Ye

CONTACT

[email protected]

0086-13916720995

About this study

The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pathological and clinical diagnosis of advanced hepatobiliary malignancy requiring immunotherapy or combination immunotherapy after evaluation according to clinical guidelines
  • Signed and dated informed consent form
  • Commitment to comply with research procedures and co-operation in the implementation of the full research process
  • aged 18-75 years old
  • The patient is in good general condition with an expected survival of > 6 months

Exclusion criteria

  • Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
  • Intestinal perforation, complete intestinal obstruction
  • Uncontrolled diabetes patients or fasting blood glucose levels ≥11 mmol/L on the day of the trial
  • Pregnant women and women who may be pregnant, women who are breastfeeding.
  • Non-compliant person

Treatment and study plan

Primary outcomes

  1. Evaluation the responses to immunotherapy of advanced hepatobiliary malignancy

    Time frame: up to 9 weeks

    The value of 68Ga-grazytracer PET in monitoring responses to immunotherapy of advanced hepatobiliary malignancy

  2. Standardized uptake value(SUV)

    Time frame: up to 9 weeks

    SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions

  3. Target-to-background ratio(TBR)

    Time frame: up to 9 weeks

    68Ga-grazytracer uptake ratio of tumor lesions to mediastinum and liver blood pool on PET/CT images.

Secondary outcomes

  1. Progress free survival

    Time frame: 1 years

    Progress free survival

  2. Overall survival

    Time frame: 1 years

    Overall survival

Study contacts

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

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

A Prospective Study on Investigating the Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Dec 11, 2024

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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