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

NCT04138342 | Unknown Phase 1 DMC

• 1 other identifier: Qassim QDs-VELD
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Breast Cancer; Skin Cancer; Skin Diseases

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Stable topical quantum dots coated veldoreotide

  three months

Study Arms (2)

Quantum dots nanoparticles group

ACTIVE COMPARATOR

A group of female volunteers infected with breast cancer will receive topical Quantum dots in different dosage forms.

Drug: Quantum dots coated with veldoreotide

Topical approved placebo cream

PLACEBO COMPARATOR

A group of female volunteers infected with breast cancer will receive placebo cream as a negative control.

Drug: Topical approved placebo

Interventions

Quantum dots coated with veldoreotide DRUG

The active group will receive Quantum dots coated with veldoreotide in different topical dosage forms as an anti-cancer drug.

Also known as: Topical cream

Quantum dots nanoparticles group

Topical approved placebo DRUG

The placebo group will receive topical FDA approved in different dosage forms as a negative control drug.

Also known as: Topical placebo gel or cream

Topical approved placebo cream

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women, 25 to 60 years old.
• Breast biopsy within 60 days of registration (dosing) without proof of aggressive cancer in any specimen;
• 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);
• Participants performed traditional regional radical therapy (modified or moderate radical mastectomy) with or without neoadjuvant/adjuvant chemotherapy or radiotherapy;
• 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.

You may not qualify if:

• Patients have previously received any other treatment or have begun adjuvant therapy.
• There are any comorbidities that may increase the level of sex hormones: pituitary adenomas, ovarian cancers, thymic carcinomas, etc.
• 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.
• Patients have been diagnosed with other test drugs for the next 2 months.
• 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.
• Patients have a family history of endometrial, reproductive or other gynecological malignancies. Transvaginal testing indicated more severe ovary defects and endometrial thickening.
• 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.
• 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.
• 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.
• 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).

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (4)

Assiut Clinic

Asyut, 71526, Egypt

NOT YET RECRUITING

Buraidah Clinic

Buraidah, Al Qassim, 51171, Saudi Arabia

RECRUITING

Faculty of Pharmacy

Buraidah, Al-Qassim Region, 51452, Saudi Arabia

NOT YET RECRUITING

Pharmaceutics dept., Faculty of Pharmacy, Qassim University

Buraidah, Al-Qassim Region, 51452, Saudi Arabia

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 10602908 RESULT

• 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.

  PMID: 16478735 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Skin Neoplasms; Skin Diseases

Interventions

Floderm topical cream

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ahmed AH Abdellatif, PhD

  Qassim University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed AH Abdellatif, PhD

CONTACT

+966507726856; a.abdellatif@qu.edu.sa

Ahmed AH Abdellatif, PhD

CONTACT

+966507726856; ahmed.a.h.abdellatif@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 24, 2019
• Study Start: September 15, 2019
• Primary Completion: June 14, 2021
• Study Completion: December 13, 2022
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (3); EG (1)