CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF VRP 1620 IN PATIENTS OF BREAST CANCER.

A double blind, multi-centric, randomized controlled clinical trial to evaluate the efficacy and safety of VRP-1620 in increasing the sensitivity of sonomammography and lateral chest X-ray in patients of breast cancer.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/07/003854

Enrollment

220

Registered

2013-07-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- breast cancer

Interventions

Intervention1: Placebo: The placebo will be a pharmacologically inactive substance and will be exactly like the study drug in appearance,packaging,odor Intervention2: VRP 1620: 0.8Î¼g/kg body weight u

Eligibility

Inclusion criteria

Inclusion criteria: Female subjects in the age group of 18-65 years Subjects presenting for routine breast cancer examination Subjects with suspected clinical diagnosis of breast cancer Subjects who have not undergone any biopsy for breast cancer Subjects willing to give written informed consent

Exclusion criteria

Exclusion criteria: Subjects with coagulopathy history of stroke deep vein thrombosis cardiac dysfunction uncontrolled hypertension history of cardiac surgery brain tumor or brain metastasis, and sarcomas Subject with respiratory disorder Pregnancy or lactation Subject has undergone a breast augmentation or breast implant Subject has significant existing breast trauma Subjects with abnormal renal & liver functions Subjects allergic to VRP-1620 and related products A marked baseline prolongation of QT/QTc interval eg repeated demonstration of a QTc interval grater then 450 milliseconds (ms) A history of additional risk factors for TdP eg heart failure, hypokalemia, family history of Long QT Syndrome) The use of concomitant medications that prolong the QT or QTc interval. Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data

Design outcomes

Primary

Measure	Time frame
Primary objective of the study is to evaluate the efficacy of VRP 1620 in increasing the sensitivity of sonomammography and lateral chest X-ray in the detection of solid breast tumors as evidenced by the change in positive predictive value PPV of each investigative modalityTimepoint: Approximately 10 days	—

Secondary

Measure	Time frame
To assess the safety of VRP 1620 post administrationTimepoint: Approximately 10 days	—

Countries

India

Contacts

Public ContactPankaj Patial

Venus Remedies Limited

medcom@vmrcindia.com01795302126

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026