Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02970786
• Other study ID #: AK-2015-1
• Status: Recruiting
• Phase: Phase 1
• First received: November 15, 2016
• Last updated: November 18, 2016
• Start date: November 2016

Study information

• Verified date: November 2016
• Source: Rigshospitalet, Denmark
• Contact: Malene M Clausen, MD, PhD
• Phone: +4522524536
• Email: malene.martini.clausen[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment.

This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).

Description:

The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment.

This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).

The primary end points are safety, biodistribution and dosimetry of 68Ga-NODAGA-E[c(RGDyK)]2. In addition, the quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 will be compared to the expression of integrin αvβ3 measured directly in tumor tissue obtained by surgery or biopsies. The study will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Diagnosed with neuroendocrine cancer, breast cancer or ovarian cancer

• Capable of understanding and giving full informed consent

Exclusion Criteria:

• Pregnancy

• Lactation

• Obesity (weight above 140 kg)

• Claustrophobia

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Neuroendocrine
• Neuroendocrine Carcinoma
• Ovarian Cancer

Intervention

Drug:
• Injection of 68Ga-NODAGA-E(c[RGDyK])2
Following one injection of 68Ga-NODAGA-E(c[RGDyK])2 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection

Locations

Country	Name	City	State
Denmark	Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biodistribution	Change in biodistribution estimated by PET	2 hours	No
Primary	Dosimetry	Dosimetry will be calculated with the use of OLINDA/EXM software (mSv) based on repeated PET imaging with the radiotracer 68Ga-NODAGA-E(c[RGDyK])2.	2 hours	No
Primary	Safety of 68Ga-NODAGA-E(c[RGDyK])2 PET as measured by the number of participants with adverse events and significant changes in vital signs, electrocardiogram, and laboratory data.		48 hours	Yes
Secondary	Quantitative uptake of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2 in tumor tissue	The patients will be PET scanned 10 minutes, 1 hour and 2 hours post injection of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2. These timepoints will be used for assessment of tumor uptake by the use of maximum and mean standardized uptake value (SUV).	2 hours	No