68Ga-DOTA-F2 PET/CT in Patients With Various Types of Cancer

NCT05637034 | Unknown DMC

• 1 other identifier: I-22PJ292
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the potential usefulness of 68Ga-DOTA-F2 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 18F-FDG PET/CT.

Conditions

Tumor, Solid

Outcome Measures

Primary Outcomes (2)

• Standardized uptake value (SUV)

  Standardized uptake value (SUV) of 68Ga-DOTA-F2 and 18F-FDG for each primary tumor of subject or suspected lymph metastasis

  through study completion, an average of 1 year

• Lession detection ability

  Lession number detected by 68Ga-DOTA-F2 and 18F-FDG PET/CT

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Sensitivity

  through study completion, an average of 1 year

• Specificity

  through study completion, an average of 1 year

• Radiation Dosimetry

  30 days

Study Arms (1)

68Ga-DOTA-F2 PET/CT and 18F-FDG

EXPERIMENTAL

Each subject receive a single intravenous injection of 68Ga-DOTA-F2 and 18F-FDG, and undergo PET/CT imaging within the specified time.

Diagnostic Test: 68Ga-DOTA-F2 PET/CT and 18F-FDG

Interventions

68Ga-DOTA-F2 PET/CT and 18F-FDG DIAGNOSTIC_TEST

Each subject receive a single intravenous injection of 68Ga-DOTA-F2 and 18F-FDG, and undergo PET/CT imaging within the specified time.

68Ga-DOTA-F2 PET/CT and 18F-FDG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is aged 18 years or older
• Signed Informed Consent
• Subject is pathologically confirmed with a malignant tumor
• Subject is judged to be in good general condition by the investigator based on medical history, physical examination including vital signs and clinical laboratory tests, besides the diagnosis of malignant tumor
• Female subjects should be post-menopausal or surgically sterile or using effective contraceptive with the negative pregnancy test

You may not qualify if:

• Subject has a previous or ongoing recurrent or chronic disease, other than malignant tumor, at high risk to interfere with the evaluation of the trial according to the judgment of the investigator
• Subject with non-malignant lesions;
• Subject with the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
• Subject is potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking union medical college hospital

Beijing, Beijing Municipality, 10010, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Fang Li, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peipei Wang, MD

CONTACT

18511395988; wpp199411@163.com

Fang Li, MD

CONTACT

13901054627; lifang@pumch.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 5, 2022
• Study Start: September 15, 2022
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)