Usefulness of 18F-FRP170

JRCT ID: jRCTs031190133

Registered date:13/11/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Head and Neck Cancer
• Date of first enrollment: 13/11/2019
• Target sample size: 10
• Study type: Interventional

Intervention(s)

18F-FRP170-PET/CT and 18F-FMISO-PET/CT are conducted at Southern TOHOKU hospital as an outpatient. 18F-FRP170 is administered in a rang e of 185-370 MBq with a concentration of less than 4 MBq/kg of a standard dose. Dynamic scan of local lesion for 30 min from start, and 20 minutes scanning of local lesion at 60 min and 120 min after the administration of 18F-FRP170.
18F-FMISO is administered in a range of 185-370 MBq with a concentration of 3.7 MBq/kg of a standard dose. Dynamic scan of local lesion for 30 min from start, and 20 minutes scanning of local lesion at 60 min, 120 min, and 240 min after the administration of 18F-FMISO.

Outcome(s)

Primary Outcome

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.
1) SUVmax
2) T/N (tumor/normal tissue ratio,
SUVtumor/SUVnormal tissue)
3) T/B (tumor/blood ratio, SUVtumor/SUVblood)
4) T/M (tumor/muscle ratio,
SUVtumor/SUVmuscle),

• Secondary Outcome: Time-Activity Curves0-30min after injection

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Takai Yoshihiro