sefulness of 18F-FRP170

Phase 2

• Conditions: Head and Neck Cancer

• Registration Number: JPRN-jRCTs031190133
• Lead Sponsor: Takai Yoshihiro

Brief Summary

This clinical trial required test dates for both FRP170 and FMISO PET/CT.At the Center,these tests could only be performed on a fixed day of the week.Therefore,a period of about two weeks was needed to perform these tests.Since the subjects were cancer patients that required treatment as soon as possible,It would have been difficult for them to participate in this clinical trial by postponing their treatment for two weeks.Therefore,it ended with 0 cases.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-13
• Study Completion: 2022-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Patient or substitute for patient has voluntarily signed the informed consent
2. Patients' age 20=<,<80
3. Patients have histopathologically proven malignant tumors and tumor lesions more than
2cm in diameter on CT or MRI
4. Patients who falls under any of the following categories:
A) Patients newly diagnosed with malignant
tumors have not received anti-cancer therapy yet
B) Patients newly diagnosed with tumor
recurrence and progression by CT or MRI have not received
newly anti-cancer therapy yet
C) Patients without schedule of effective
medication to anti-cancer nor receiving radiation before
the completion of the second examination
5. Patients who have not previous history of radiotherapy or who have radiotherapy more than
3 months before
6. Patients with ECOG PS score 0-2
7. Patients who can be taken 18F-FRP170-PET
and 18F-FMISO-PET Examination within 3 weeks
8. Patients who can be held in supine position
during PET examinations
9. Patients with stable main organ functions such as liver or kidney on hematologic test for the past
6 months
WBC>=3,000/mm3 and <=12,000/mm3
ANC>=1,500/mm3
Platelets>=100,000/mm3
AST(GOT) =<2.5x the ULN for the reference lab
ALT(GPT) =< 2.5 x the ULN for the reference lab
Creatinine =<1.5mg /dL
10. Patients have no clinically sig nificant
abnormalities in 12-lead ECG for the past 6 months

Exclusion Criteria

1. Patients with significant complications.
1) Poorly-controlled diabetes mellitus
2) Poorly-controlled hypertension
3) Pulmonary disease with respiratory insufficiency
4) Renal disease(chronic renal failure,acute renal failure,nephrotic syndrome,artifical dialysis,etc)
5) Heart disease with heart failure symptoms
2. Patients who were enrolled in this clinical study or the other study within 3months before the
initial informed consent or who are participating and will participate in other clinical study.
3. Patients who are pregnancy and want to become pregnant and male who want his partner to become
pregnant.
4. Patients with complications of mental disease or psychological symptom who can't be participated in this
clinical study or who are taking antipsychotics.
5. Patients with poorly-controlled epilepsy.
6. Patients whom a principal investigator or sub-investigator determined ineligible.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To obtain the following parameters at 1 h, 2 h, and 4 h after drug administration from 18F-FRP170-PET and 18F-FMISO-PET PET studies.<br> 1) SUVmax<br> 2) T/N (tumor/normal tissue ratio,<br> SUVtumor/SUVnormal tissue)<br> 3) T/B (tumor/blood ratio, SUVtumor/SUVblood)<br> 4) T/M (tumor/muscle ratio,<br> SUVtumor/SUVmuscle),

Secondary Outcome Measures

Name	Time	Method
Time-Activity Curves0-30min after injection