Ga-68-DOTA-RGD2 PET/CT in patients with head and neck cancer: a potential tracer to image angiogenesis in tumors.

Completed

Conditions: HNSCC
Head and neck cancer
10027656

Registration Number: NL-OMON43594

Lead Sponsor: Department of Radiology and Nuclear Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

- Proven HNSSC of the oral cavity, oro- and hypopharynx, or larynx
- At least one lesion with a diameter of at least 1.5 cm
- A diagnostic CT or MRI scan is obtained within 4 weeks prior to screenings visit
- Planned surgery as primary treatment
- * 18 years
- Ability to provide written informed consent

Exclusion Criteria

- Contra-indications for PET: pregnancy, breast-feeding, or severe claustrophobia
- Abnormal renal function
* creatinine clearance * 60 mL/min according to the formula of Cockroft and Gault
- Abnormal liver function
* ALAT or ASAT level more than 3 times the upper limit of normal range
* Bilirubin more than 2 times the upper limit of normal range
- Other serious illness

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the uptake of Ga-68-DOTA-RGD2 in the tumor lesions<br /><br>as quantified by PET/CT. Therefore, tracer uptake in tumor tissue, liver,<br /><br>muscle and blood will be determined quantitatively (Standardized Uptake Values,<br /><br>SUVs). With the SUVs, tumor-to-blood and tumor-to-background ratios are<br /><br>calculated. SUVs are obtained by drawing regions of interest, drawn by an<br /><br>investigator, blinded for the immunohistochemical data. Positive ratios are<br /><br>defined as a ratio higher or equal to 2.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Additional study parameters are the pharmacokinetics, pharmacodynamics,<br /><br>biodistribution and in vivo stability of Ga-68-DOTA-RGD2, and integrin v3<br /><br>expression of the tumor lesion as determined immunohistochemically. </p><br>