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The clinical application and evaluation of novel PET-CT molecular probes for multiple tumors

The clinical application and evaluation of novel PET-CT molecular probes for multiple tumors

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058108
Enrollment
Unknown
Registered
2022-03-29
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumor

Interventions

Gold Standard:Pathology
Index test:Standard uptake value(SUV)
Standard uptake value max(SUVmax)
Standard uptake value mean(SUVmean)
Tumor to background ratio(TBR)

Sponsors

Harbin Medical University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.The subjects voluntarily signs the informed consent, and are able to complete the test according to the protocol requirements, with good compliance and follow-up; 2.The subjects are over 18 years of age; 3.The subjects signs informed consent; 4.The subjects were definitely diagnosed with the tumor which were proved by histology and(or) cytology including gastrointestinal tract,pancreas,lung,nervous or unknown primary tumor. 5.Subjects should have at least one known neoplastic lesion below the mandible and parotid gland level, and morphological imaging (CT, MRI, ultrasound) of at least one dimension of at least 1 cm should be performed within 4 months prior to study scanning. A positive lesion was defined as an increased tracer intake compared to background and was unlikely to be due to a physiological or benign cause. 6.Subjects should undergo routine clinical 18-FDG PET/CT whole-body imaging within 3 months prior to or scheduled for 3 months after the study scan. 7.Female subjects should be (a) postmenopausal, or (b) surgically infertile, or (c) using an effective contraceptive method and undergoing a negative pregnancy test.

Exclusion criteria

Exclusion criteria: 1.Has a pre-existing or ongoing recurrent or chronic disease that, in the investigator's judgment, is at high risk of interfering with the conduct or evaluation of the trial. 2.In the past 12 months, the subject has been exposed to ionizing radiation in other studies ( >1 mSv); 3. The subject has recently participated in or is currently participating in another prospective interventional clinical trial; 4.Subjects were unwilling to avoid abnormal, unaccustomed, or vigorous physical activity from 4 days before tracer injection to 1 day after tracer injection; 5.Subject may be pregnant (urine hCG test if in doubt) or breastfeeding; 6.Subjects are unwilling or unable to perform all study procedures or are deemed unsuitable in any way by the principal investigator; 7.The subject is mentally or legally incapacitated; 8.Subjects had contraindications for MR scans; 9.Subjects suffer from claustrophobia or cannot tolerate confinement during PET/MR scans; 10.The subjects had impaired kidney function; 11.Subjects with contraindicated use of Buscopan diseases: glaucoma, paralytic ileus, severe ulcerative colitis, or myasthenia gravis; 12.The patient had used drugs regularly (including "recreational use") or had a recent history of substance abuse (including alcohol) within the year prior to signing the informed consent; 13.Need to drainage symptomatic ascites or pleural effusion, pericardial effusion; 14.Live attenuated vaccine received within 4 weeks prior to initial administration or planned during the study period; 15.Major surgical procedure other than diagnosis or unhealed wound, ulcer or fracture in the 28 days prior to initial administration; 16.Prior allogeneic hematopoietic stem cell or solid organ transplantation; 17.Subjects with other factors that the investigator considered inappropriate for participation in the study.

Design outcomes

Primary

MeasureTime frame
Standard uptake value(SUV);SEN, SPE, ACC, AUC of ROC;

Secondary

MeasureTime frame
Tumor to background ratio(TBR);

Countries

China

Contacts

Public ContactKezheng Wang

Harbin Medical University Cancer Hospital

wangkezheng9954001@163.com+86 15945180084

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026