NCT06159049

Brief Summary

Fibroblast activation protein (FAP) emerges as a highly promising target for cancer diagnostic imaging and targeted radionuclide therapy. To exploit the therapeutic potential of current FAP inhibitors (FAPIs), this study presented the design and synthesis of a series of FAPI dimers to increase tumor uptake and retention. Preclinical evaluation and a pilot clinical PET imaging study were conducted to screen the lead compound with the potential for radionuclide therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
Last Updated

December 6, 2023

Status Verified

September 1, 2023

Enrollment Period

Same day

First QC Date

September 17, 2023

Last Update Submit

November 28, 2023

Conditions

Gastrointestinal Cancer

Keywords

FAPI dimer

Outcome Measures

Primary Outcomes (2)

  • Number of discrepancies between [68Ga]Ga-LNC1013 and 68Ga-FAPI-46 or 18F-FDG PET scans

    Compare the diagnostic performance between \[68Ga\]Ga-LNC1013 and 68Ga-FAPI-46 or 18F-FDG in patients with gastrointestinal cancer

    5 months

  • SUVmaxFAPI and SUVmaxFDG for each target (Standardized Uptake Value)

    Comparison of 68Ga\]Ga-LNC1013, 68Ga-FAPI-46 and 18F-FDG Standardized Uptake Value in the primary tumor and possible metastases

    5 months

Interventions

68Ga-FAPI dimer(68Ga-LNC1013)DIAGNOSTIC_TEST

68Ga-LNC1013 was evaluated in a pilot clinical PET imaging study involving seven patients with gastrointestinal cancer.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Claustrophobia (unable to accept PET/CT scanning)

You may qualify if:

  • Histologically and/or clinically confirmed and/or suspicious of gastrointestinal cancer.
  • Signed informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jian Li

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Shuo Hu, Dr

    Xiangya Hospital, Central South University, Changsha, P.R. China

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2023

First Posted

December 6, 2023

Study Start

July 21, 2022

Primary Completion

July 21, 2022

Study Completion

November 25, 2022

Last Updated

December 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)