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Trial record 99 of 1733 for:    Recruiting, Not yet recruiting, Available Studies | Autoimmunity

Characterizing IgG4-RD With 68Ga-FAPI PET/CT

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ClinicalTrials.gov Identifier: NCT04125511
Recruitment Status : Not yet recruiting
First Posted : October 14, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as IgG4-related disease.And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research.Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of IgG4-related disease.

Condition or disease Intervention/treatment Phase
IgG4-related Disease Drug: 68Ga-FAPI Early Phase 1

Detailed Description:
Immunoglobulin G4-related disease (IgG4-RD) is an immune-mediated fibroinflammatory condition that is capable of affecting multiple organs. Common forms of presentation include:Type 1 (IgG4-related) autoimmune pancreatitis (AIP),IgG4-related sclerosing cholangitis, major salivary gland enlargement or sclerosing sialadenitis; Orbital disease, often with proptosis and retroperitoneal fibrosis. The involved organs share a number of core pathologic features and striking clinical and serologic similarities, including tumor-like swelling of involved organs, a lymphoplasmacytic infiltrate enriched in IgG4-positive plasma cells, and a variable degree of fibrosis that has a characteristic "storiform" pattern. 68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and it might be a pan-tumor PET agent. Recently we have reported a case of IgG4-related disease revealed by 68Ga-FAPI and 18F-FDG PET/CT which showed FAPI was not more tumor-specific than FDG, furthermore,it might be more sensitive than FDG in detecting a certain type of inflammations—like the pancreatic lesion. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of IgG4-related disease.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Characterizing IgG4-related Disease With 68Ga-FAPI PET/CT
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 68Ga-FAPI, PET/CT
Inject 68Ga-FAPI and then perform PET/CT scan.
Drug: 68Ga-FAPI
Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of IgG4-RD by PET/CT.
Other Name: 68Ga-fibroblast activating protein inhibitors




Primary Outcome Measures :
  1. Metabolic parameters [ Time Frame: through study completion, an average of 1 year ]
    Total Lesion Glycolysis (TLG) of focal lesions are measured on 68Ga-FAPI PET/CT.


Secondary Outcome Measures :
  1. Diagnostic value [ Time Frame: through study completion, an average of 1 year ]
    Diagnostic value of 68Ga-FAPI PET/CT for IgG4-RD in comparison with 18F-FDG PET/CT.

  2. adverse events [ Time Frame: through study completion, an average of 1 year ]
    Number of participants and kind of adverse events as a measure of safety.

  3. Disease burden assessement [ Time Frame: through study completion, an average of 1 year ]
    Correlation between disease burden assessed on 68Ga-FAPI PET/CT and clinical parameters for IgG4-RD.

  4. FAPI expression and SUV [ Time Frame: through study completion, an average of 1 year ]
    Correlation between FAPI expression and SUV in PET

  5. Prediction value [ Time Frame: through study completion, an average of 1 year ]
    Prediction value of 68Ga-FAPI PET/CT for IgG4-RD in therapy response assessment



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • suspected or confirmed untreated IgG4-RD patients;
  • 18F-FDG PET/CT within two weeks;
  • signed written consent.

Exclusion Criteria:

  • pregnancy;
  • breastfeeding;
  • known allergy against FAPI
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125511


Contacts
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Contact: Li Huo, M.D. 86-10-69155537 huoli@pumch.cn
Contact: Yaping Luo, M.D. 86-10-69157033 luoyaping@live.com

Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Li Huo, M.D. Peking Union Medical College Hospital

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04125511     History of Changes
Other Study ID Numbers: PekingUMCHFAPI
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Immunoglobulin G4-Related Disease
Autoimmune Diseases
Immune System Diseases
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs