Clinical trial · Interventional

Clinical Study of 68Ga Labeled HER2 Affibody Analogues

Clinical Study of 68Ga Labeled HER2 Affibody Analogues in Healthy Volunteers and Patients With Breast or Gastric Tumors

NCT05411432CI-TRIAL-00058986unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The purpose of this study is to assess the dosimetric properties of the positron emission tomography (PET) imaging probe 68Ga labeled HER2 Affibody analogues and preliminarily evaluate its diagnosis value in patients with breast or gastric tumors.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
HER2-positive Breast Cancer and Gastric Cancer	Gastric Neoplasm	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
68Ga labeled HER2 Affibody	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
SUV of organs
timeFrame
0, 0.5, 1.0, 2.0,3.0 and 4.0 hours after injection
description
The standardized uptake values (SUV) in deferent organs

Secondary outcomes (1)

measure
radioactivity of blood sample
timeFrame
1, 3, 5, 10, 30,60, 90, 120, 150, 180 and 240 minutes
description
blood samples are obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, 180 and 240 minutes after the injection, for time-radioactivity curve calculations.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

* patients with breast or gastric cancers: diagnosed by MR and ready for surgery

Exclusion Criteria:

* refuse or cannot endure surgery pregnant women

References

Publications (0)

Data not yet available

No reference posted for this study.