Topical Fluorescent Nanoparticles Conjugated Somatostatin Analog for Suppression and Bioimaging Breast Cancer

Fluorescent Nanoparticles Conjugated Long-acting Somatostatin Analog for Potent Suppression and Bioimaging Breast Cancer

Breast cancer is a communal malignant disease between Saudi females, with a popularity of 21.8%. Since binding to somatostatin receptors (SSTR) induces no immunogenicity in vivo, somatostatin analog (veldoreotide) (VELD) may be suitable for delivering anti-cancer drugs to target and bioimaging the cancer cells. This work aimed to deliver CdS/ZnS core-shell type quantum dots with carboxylic acid-functionalized (QDs-COOH) which is bioimaging and anticancer nanoparticles decorated VELD as SSTR agonist with anti-cancer activity in the form of topical cream to be deposited deep in the breast periphery.

Study Overview

• Status: Unknown
• Conditions: Skin Diseases; Breast Cancer; Skin Cancer
• Intervention / Treatment: Drug: Quantum dots coated with veldoreotide; Drug: Topical approved placebo

Detailed Description

QDs-COOH will be conjugated to the N terminal of phenylalanine of VELD when the reaction proceeded at pH 7. Topical cream will be adapted to deliver the conjugated system for maximum deposition through breast cancer cells using emulsion technology. The formulated nanoparticles and cream will be characterized for size using dynamic light scattering, drug-polymer interaction using FTIR, and morphology using SEM. Cellular uptake, permeability and cell viability study of the successful system of interest will be studied in cell culture models using different breast cell lines. Moreover, the in vivo study will also proceed on rats induced breast cancer. Finally, the nanoparticles loaded in a topical cream will be applied with clinical trial approvement on the human breast cancer for bioimaging and treating breast cancer. This work is to present a novel formulation for treatment and bioimaging of breast cancer which can deliver safely to the patients in a high dose to the affected tumor cells.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71526
    • Not yet recruiting
    • Assiut Clinic
    • Contact: Ahmed AH Abdellatif, PhD; Phone Number: +966507726856; Email: a.abdellatif@qu.edu.sa
• Saudi Arabia
  • Al Qassim
    • Buraidah, Al Qassim, Saudi Arabia, 51171
      • Recruiting
      • Buraidah Clinic
  • Qassim
    • Buraidah, Qassim, Saudi Arabia, 51452
      • Not yet recruiting
      • Faculty of pharmacy
    • Buraidah, Qassim, Saudi Arabia, 51452
      • Not yet recruiting
      • Pharmaceutics dept., Faculty of Pharmacy, Qassim University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women, 25 to 60 years old.
2. Breast biopsy within 60 days of registration (dosing) without proof of aggressive cancer in any specimen;
3. Invasive breast cancer verified by histology of ER ≥ 10% (all test results should be checked and validated by the Pathology Department of the involved institution);
4. Participants performed traditional regional radical therapy (modified or moderate radical mastectomy) with or without neoadjuvant/adjuvant chemotherapy or radiotherapy;
5. Hemoglobin ≥ 90 g / L, neutrophils ≥ 1.5 × 109/L, platelets ≥ 75 × 109/L, AST and ALT ≤ 2.5 times the upper limit for natural (ULN), creatinine serum and urea nitrogen ≤ ULN.

Exclusion Criteria:

1. Patients have previously received any other treatment or have begun adjuvant therapy.
2. There are any comorbidities that may increase the level of sex hormones: pituitary adenomas, ovarian cancers, thymic carcinomas, etc.
3. There are any comorbidities that may decrease sex hormone rates such as hyperthyroidism, hypothyroidism, cirrhosis, extreme obesity, Turner syndrome, lack of sex hormone synthetase, intracranial tumors, pituitary atrophy, etc. Patients have undergone and expected suppression of ovariectomy and ovarian activity.
4. Patients have been diagnosed with other test drugs for the next 2 months.
5. People of child-bearing age who are not willing to take effective contraception through therapy. Serious non-maligned tumor comorbidities can impair long-term follow-up.
6. Patients have a family history of endometrial, reproductive or other gynecological malignancies. Transvaginal testing indicated more severe ovary defects and endometrial thickening.
7. Patients had thrombotic incidents such as a cerebrovascular injury (including a transient ischemic attack), deep venous thrombosis, and pulmonary embolism within 6 months of the start of the research.
8. Serious insufficiency of the liver with Child-Pugh C class. Serious heart disease of New York Heart Association (NYHA) class ≥III. Patients are considered to be severely allergic to medications.
9. Patients have a record of other malignancies over the last five years, with the exception of cutaneous basal cell carcinoma and cervical in situ carcinoma that has been healed. In other instances, investigators do not feel the topics are acceptable for study participants.
10. Pregnant or lactating women (women of childbearing age should receive a negative pregnancy test within 14 days of the first dosage or, if pregnant, clinicians are required to undergo an ultrasound review to exclude childbirth).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Quantum dots nanoparticles group; A group of female volunteers infected with breast cancer will receive topical Quantum dots in different dosage forms.	Drug: Quantum dots coated with veldoreotide; The active group will receive Quantum dots coated with veldoreotide in different topical dosage forms as an anti-cancer drug.; Other Names: Topical cream
PLACEBO_COMPARATOR: Topical approved placebo cream; A group of female volunteers infected with breast cancer will receive placebo cream as a negative control.	Drug: Topical approved placebo; The placebo group will receive topical FDA approved in different dosage forms as a negative control drug.; Other Names: Topical placebo gel or cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth inhibition was measured using the sulforhodamine B-based assay.	QDs-VELD have anticancer activity. This study will be determined by measuring the growth inhibition of anticancer activity for QDs-VELD.	6 months
Amount of QDs-VELD fluorescent QDs-VELD in the breast periphery due to the fluorescence of QDs using flow cytometry.	The bioimaging effect for scintigraphy of breast cancer.	6 months
Growth inhibition was measured by visual determination of breast cancer cells.	QDs-VELD have anticancer activity. This study will be determined by measuring the growth inhibition of anticancer activity for QDs-VELD.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stable topical quantum dots coated veldoreotide	Stability test will be studied for dosage forms. The test will carried out by standing the products on shelf life for three months. The stability test will be recorded using high performance liquid chromatography each thee days.	three months

Collaborators and Investigators

• Sponsor: Al-Azhar University

Publications and helpful links

General Publications

• Clive S, Gardiner J, Leonard RC. Miltefosine as a topical treatment for cutaneous metastases in breast carcinoma. Cancer Chemother Pharmacol. 1999;44 Suppl:S29-30. doi: 10.1007/s002800051114.
• Doroshow JH. Redox modulation of chemotherapy-induced tumor cell killing and normal tissue toxicity. J Natl Cancer Inst. 2006 Feb 15;98(4):223-5. doi: 10.1093/jnci/djj065. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2019
• Primary Completion (ANTICIPATED): June 14, 2021
• Study Completion (ANTICIPATED): December 13, 2022

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (ACTUAL): October 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 24, 2019
• Last Update Submitted That Met QC Criteria: October 23, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Skin Diseases
• Other Study ID Numbers: Qassim QDs-VELD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The authors could not decide until now a plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No