NCT05891028

Brief Summary

Positron labeled camptothecin based PET imaging is a new imaging technique that uses positron isotopes such as 68Ga/64Cu for PET/CT (MR) imaging. It is expected to have significant clinical significance in staging and detecting primary and metastatic head and neck cancer, oral cancer, and colorectal cancer tumors.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for early_phase_1 colorectal-cancer

Timeline
Completed

Started May 2023

Shorter than P25 for early_phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

May 7, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

June 8, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

May 26, 2023

Last Update Submit

June 6, 2023

Conditions

Colorectal Cancer

Keywords

Colorectal CancerPET/CTCPT

Outcome Measures

Primary Outcomes (2)

  • Dosimetric distribution of radiopharmaceuticals

    Input the data of 5-6 patients into HERMES software, and analyze the dose distribution of radioactive drugs in human body through HERMES software

    2 months

  • Standardized uptake value

    The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor will be measured. SUV were obtained by a self-made software and referring to phantom study.If the SUV value cannot be obtained, the COUNTS of target organ/background ratio between the lesion and surrounding tissues shall be used for calculation.

    1 year

Secondary Outcomes (1)

  • Adverse events collection

    1 year

Study Arms (2)

68Ga-EB-ss-CPT PET/CT scan

EXPERIMENTAL

68Ga-EB-ss-CPT PET/CT scan Dosimetry study about 6 patients were injected with 3 (MBq) per kilogram body weight of 68Ga-EB-ss-CPT PET/CT in one dose intravenously and underwent wholebody scan at 5min#30min#60min#120min#240min, then analysis of dosimetric distribution ofradiopharmaceuticals in human body by HERMES software.

Drug: 68Ga-EB-ss-CPT

64Cu-EB-ss-CPT PET/CT scan

EXPERIMENTAL

64Cu-EB-ss-CPT PET/CT scan Dosimetry study about 6 patients were injected with 2 (MBq) per kilogram body weight of 64Cu-EB-ss-CPT PET/CT in one dose intravenously and underwent wholebody scan at 30min#8h#12h#24h#48h, then analysis of dosimetric distribution ofradiopharmaceuticals in human body by HERMES software.

Drug: 64Cu-EB-ss-CPT

Interventions

68Ga-EB-ss-CPTDRUG

68Ga-EB-ss-CPT were intravenous injected into the patients before PET/CT scans

Also known as: 68Ga
68Ga-EB-ss-CPT PET/CT scan
64Cu-EB-ss-CPTDRUG

64Cu-EB-ss-CPT were intravenous injected into the patients before PET/CT scans

Also known as: 64Cu
64Cu-EB-ss-CPT PET/CT scan

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • In the near future (within 2 months), patients who plan to undergo puncture biopsy or undergo tumor surgical treatment or are clinically highly suspected of cancer (including primary and tumor recurrence and metastasis)
  • Able to understand and voluntarily sign informed consent forms, with good compliance

You may not qualify if:

  • Severe abnormalities in liver and kidney function
  • Suffering from claustrophobia or other mental illnesses
  • Pregnant, pregnant, and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Science & Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Zhaohui Zhu

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Rongxi Wang

CONTACT

+8615584172170zhzwrx.123@163.com

Zhaohui Zhu

CONTACT

+8619800370331pumch_jacobwong@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 6, 2023

Study Start

May 7, 2023

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

June 8, 2023

Record last verified: 2023-05

Locations

CN(1)