NCT06203574

Brief Summary

This study will investigate the safety and preliminary diagnostic efficacy of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 in pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. Then, this study will provide a new method for the noninvasive target-specific diagnosis of pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. PET imaging of TROP-2 will be integrated to TROP-2-targeted therapies in some of the included patients. Therefore, PET imaging with \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 will help select patients for targeted therapy and monitor treatment responses after the treatment.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

January 3, 2024

Last Update Submit

June 14, 2024

Conditions

Positron-Emission TomographyNeoplasms

Outcome Measures

Primary Outcomes (3)

  • evaluate the safety and feasibility of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors

    The primary goal of the study is to evaluate the distribution profiles (in terms of SUVmax) of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors.

    1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4

  • evaluate the sensitivity and specificity of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression

    The secondary goal is to evaluate the sensitivity and specificity of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression.

    1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4

  • evaluate the value of TROP-2 expression determined by [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT

    The third goal is to evaluate the value of TROP-2 expression determined by \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 PET/CT in differential diagnosis, patient selection, and response monitoring in patients with solid tumors.

    1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4

Study Arms (1)

patients with solid tumors

EXPERIMENTAL

Subjects were recruited from Huashan Hospital of Fudan University.

Radiation: [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4

Interventions

[68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4RADIATION

The dose of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 was calculated based on the patient's body weight to be 3.7 MBq \[0.1 mCi\]/kg, and the method of administration was intravenous push, with one single imaging administration.

patients with solid tumors

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be between 18 and 65 years of age and of either sex.
  • Patients with colorectal cancer confirmed by puncture or surgical pathology.
  • Written informed consent signed by the subject or legal guardian or caregiver.
  • Willingness and ability to cooperate with all programs of this study.

You may not qualify if:

  • Severe hepatic or renal insufficiency;
  • Targeted therapy before radiotherapy or PET/CT scan；
  • Renal function: serum creatinine less than or equal to the upper limit of the normal range;Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range；
  • History of serious surgery in the last month. Those who have participated in other clinical trials during the same period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Fang Xie, PhD

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihui Guan, MD

CONTACT

13764308300guanyihui@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 12, 2024

Study Start

December 1, 2023

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations

CN(1)